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and <span class="elsevierStyleItalic">3&#41;</span> absence of clinical symptoms and signs due to uremia<span class="elsevierStyleSup">1</span>&#46; <span class="elsevierStyleItalic">This was based on NKF-DOQUI peritoneal dialysis guidelines because of the lack of outcome studies evaluating residual renal function in hemodialysis&#46;</span><span class="elsevierStyleBold"> </span>Recommendations that were updated in 2006 with initiation of dialysis when the eGFR was &#60;15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> as predicated by a previous evaluation of benefits and risks by the nephrologist&#44; and with eGFR &#62;15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> in symptomatic patients&#46; European guidelines recommended that dialysis should be instituted<span class="elsevierStyleSup">2</span> when the eGFR is &#60;15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; This recommendations were supported by data from the Canada and United States study &#40;CANUSA study&#41; of continuous ambulatory peritoneal dialysis<span class="elsevierStyleSup">3</span>&#46;<span class="elsevierStyleSup">&#160;</span>Later refuted by the ADEquacy of PD in MEXico &#40;ADEMEX&#41; and Hemodialysis &#40;HEMO&#41; studies<span class="elsevierStyleSup">4&#44;5</span>&#46;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</p><p class="elsevierStylePara">Data selected from the United States Renal Data System &#40;USRDS&#41; demonstrated an increase in the frequency of patients initiating dialysis &#40;hemo and peritoneal dialysis&#41;<span class="elsevierStyleSup">6</span>&#44; with estimated eGFR above 10 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; In 2005&#44; 30&#37; of patients started dialysis at eGFR values of 10-14&#46;9 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2 </span>&#44; and 15&#37; at eGFR greater than 15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2 </span>&#40;compared&#160;to 15&#37; and 4&#37; respectively&#44; in 1996&#41;&#46; The frequency of eGFR &#62;10 mlL&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> increased to 54&#37; from 25&#37; in 1996&#44; especially in patients over the age of 75 years at the time of initiation of dialysis<span class="elsevierStyleSup">6</span>&#46; The individuals who recommended the increased frequency of early initiation relied heavily on eGFR equations&#44; financial reasons&#44; and comorbidities &#40;end-stage renal disease &#40;ESRD&#41; due to diabetes &#40;43&#37; in 1996 and 44&#46;2&#37; in 2005&#41;&#46; This approach burdened the Medicare-ESRD program with 18&#44;076 more patients &#40;started&#160; in 2005&#41;&#44; at an approximate additional annual cost of &#36;641 million in 2006<span class="elsevierStyleSup">7</span>&#46;</p><p class="elsevierStylePara">Therefore&#44; the goal of this review is to evaluate current literature which describes observational and retrospective studies that were conducted to compare early or late initiation of dialysis&#44; and the influence of these practices in survival in the ESRD population&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">EARLY OR LATE INITIATION OF DIALYSIS </span>&#40;table 1&#41;</p><p class="elsevierStylePara">The suggestion that early initiation of dialysis was beneficial was first given support by Bonomini&#44; et al&#46;<span class="elsevierStyleSup">8</span>&#44; showing a 12 year survival of 77&#37; in 82 patients who started dialysis early &#40;mean creatinine clearance CrCl of 12&#46;9 ml&#47;min&#41;&#46; These results were compared with 51&#37; in 308 patients who started late &#40;CrCl of 2&#46;1 to 4&#46;8 ml&#47;min&#41;&#46; However&#44; the study did not adjust for age or other comorbidities&#46;</p><p class="elsevierStylePara">A study published by Fink&#44; et al&#46;<span class="elsevierStyleSup">9</span> with patients who initiated dialysis between April 1995 and December 1996&#44; analyzed data obtained from the Health Care Financing Administration &#40;HCFA&#41; Form 2728&#46; Creatinine levels correlated inversely with mortality risk&#46; The relationship sustained after transformation into eGFR&#44; multivariate adjustment for confounders resulted in a relative risk &#61; 0&#46;96&#59; p<span class="elsevierStyleItalic"> </span>&#60;0&#46;0001&#46;&#160;&#160;&#160;&#160;&#160;&#160;</p><p class="elsevierStylePara">In the Netherlands&#44; Korevaar&#44; et al&#46;<span class="elsevierStyleSup">10</span> investigated 253 patients starting dialysis between January 1997 and May 1999 as part of a prospective multicentre study that evaluated mortality at initiation of dialysis in late and early patients&#46; The mean follow-up time was 33-34 months&#46; Thirty-seven percent were late starters with a GFR between 4-9&#160;mL&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; There was an increased mortality risk for late starters&#44; although not statistically significant &#40;adjusted HR 1&#46;66&#44; 95&#37; confidence interval &#40;CI 0&#46;95-2&#46;89&#41;&#46; The two year survival was 75&#37; &#40;95&#37; CI&#41; in late starters&#44; and 84&#37; in early starters&#46; Traynor corroborated this data&#44; evaluating patients from the Glasgow Royal Infirmary registry&#46; He noticed a 10&#37; increased risk of hazard of death for every 1 ml&#47;min extra creatinine clearance at start of dialysis<span class="elsevierStyleSup">11</span>&#46;</p><p class="elsevierStylePara">Retrospective studies have described an increased risk of death in patients <span class="elsevierStyleItalic">starting dialysis at higher glomerular filtration rates&#46;</span></p><p class="elsevierStylePara">Beddhu&#44; et al&#46;<span class="elsevierStyleSup">12</span>&#44; analyzed patients from the United States Renal Data System &#40;USRDS&#41; Dialysis Morbidity Mortality Wave Study II to determine the associations of modification of diet in renal disease &#40;MDRD&#41; GFR formulation&#44; and also measured CrCl at the initiation of dialysis with subsequent mortality&#46; Higher eGFR at initiation of dialysis was associated with increased risk of death&#46; There were divergent results between MDRD GFR and CrCl calculations attributed to erroneous GFR estimations by the MDRD formula&#46;</p><p class="elsevierStylePara">In a later study&#44; Kazmi&#44; et al&#46;<span class="elsevierStyleSup">13</span> evaluated data from the Center for Medicare &#38; Medicaid Services between 1996 and 1999&#44; linking three incident dialysis populations and the risk of death based on GFR at initiation of dialysis&#46; After adjusting for all covariates&#44; the increased risk of death in the general population age 18&#43; years was 42&#37; with GFR &#62;10 mL&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#160;compared&#160;with GFR &#60;5 mL&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; Patients with ages 67&#43; years&#44; and a &#171;low risk&#187; subgroup without comorbidities &#40;diabetes&#44; heart failure&#44; atherosclerotic heart disease&#41; had an adjusted increased risk of 25&#37; and 39&#37;&#44; respectively&#46;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</p><p class="elsevierStylePara">The outcomes discussed above correlated with &#160;three recently published studies&#46; In the first&#44; Wright&#44; et al&#46;<span class="elsevierStyleSup">14</span>&#44; carried out a retrospective analyses of patients entering the USRDS from January 1995 to September 2006&#46; Of the total incident population &#40;896&#44;546&#41;&#44; 99&#44;231 patients had an early start &#40;eGFR &#62;15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#41; and 113&#44;510 had late start &#40;eGFR&#8804; 5 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#41;&#46; Late starters had a 12&#37; reduced risk in mortality &#40;HR&#44; 0&#46;88&#59; 95&#37; CI 0&#46;84 to 0&#46;92&#59; p &#60;0&#46;001<span class="elsevierStyleItalic">&#41;</span> whereas there was an 44&#37; increase in mortality risk associated with early starts&#58; eGFR &#62;10 to 15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2 </span>&#40;HR&#44; 1&#46;15&#59; 95&#37; CI 1&#46;15 to 1&#46;16&#59; p &#60;0&#46;001&#41; or an eGFR &#62;15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> &#40;HR&#44; 1&#46;44&#59; 95&#37; CI&#44; 1&#46;43 to 1&#46;45&#59; p &#60;0&#46;001&#41;&#46;</p><p class="elsevierStylePara">A second study by Rosansky&#44; et al&#46;<span class="elsevierStyleSup">15</span> investigated an incident ESRD population from 1996 through 2006&#44; using the Center for Medicare and Medicaid Services 2728 form&#46; The goal was to determine if early initiation had survival benefit&#46; Mortality was 20&#46;1&#37; in the early-start and 6&#46;8&#37; in the late-start groups&#46; There was a 3&#46;5-fold greater mortality with an eGFR of 15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2 </span>at the initiation of dialysis compared to an eGFR lower than 5 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; Male sex&#44; African American race and body mass index &#40;BMI&#41; &#60;25&#44; had a negative effect on survival&#46; High levels of hemoglobin &#40;10&#46;2 g&#47;dl&#41;&#44; Asian race&#44; and PCKD or glomerular disease had a positive effect on survival&#46;</p><p class="elsevierStylePara">A third retrospective study by Clark&#44; et al&#46;<span class="elsevierStyleSup">16</span> in Canada identified 25&#44;910 patients&#44; from the Canadian Organ Replacement Register&#44; between 2001 and 2007&#46; Of those patients&#44; 32&#46;6&#37; initiated dialysis at an eGFR above 10&#46;5 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2&#160;</span>and 67&#46;4&#37; at an eGFR of 10&#46;5 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2 </span>or less &#40;mean eGFR 15&#46;5&#44; Standard Deviation &#91;SD&#93; 7&#46;7 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> early initiation&#44; 7&#46;1 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> &#44; SD 2&#46;0&#44; late initiation&#41;&#46; Median follow-up 2&#46;3 years&#46; The early group had higher incidence of coronary artery disease&#44; peripheral vascular and&#44; cerebrovascular disease&#44; diabetes mellitus&#44; and lung disease &#40;early group&#58; 44&#46;9&#37;&#44; 26&#37;&#44; 16&#46;8&#37;&#44; 52&#46;7&#37;&#44; 16&#46;8&#37;&#59; late group&#58; 31&#46;3&#37;&#44; 18&#37;&#44; 13&#46;2&#37;&#44; 43&#46;4&#37;&#44; 12&#46;5&#37;&#44; respectively&#41;&#46; The adjusted mortality differential between patients with early and late initiation narrowed after one year of follow-up&#44; but the mortality rates never converged&#44; and the differential began to widen again after two years in the Kaplan-Meier survival curves&#46; After three years&#44; there were 27 more deaths per 1&#44;000 patient-years in the group with early initiation&#46;</p><p class="elsevierStylePara">The literature presented here compared early retrospective studies that associated patient survival with early initiation of dialysis&#44; in disagreement with later data&#46; The concern was the higher relative mortality rate especially with patients starting at eGFR of 10 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> or higher&#46; A possible mechanism might include&#58; recurrent episodes of myocardial ischemia and &#171;stunning myocardium&#187;&#44; with fixed systolic dysfunction directly related to ultrafiltration and hypotensive episodes&#46; Since most of the information was retrospective in nature&#44; it is subject to limitations in interpretation of the different covariants that are important in these studies&#46; In order to obtain a clearer picture it would be necessary to carry out randomized control trials&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">THE &#171;IDEAL&#187; STUDY</span></p><p class="elsevierStylePara">The Initiating Dialysis Early and Late study&#160;&#40;IDEAL&#41;<span class="elsevierStyleSup">17 </span>was designed as a randomized controlled trial to determine whether initiating dialysis early in individuals with stage V chronic kidney disease reduced the rate of death from any cause&#46; Secondary aims were to determine whether early initiation of dialysis was associated with reduction in cardiovascular and infectious events&#44; and in complications of dialysis&#46; Between July 2000 and November 2008&#44; 828 patients were recruited at 32 centers in Australia and New Zealand&#46; From these individuals&#44; 404 patients were randomly assigned to an early-start group &#40;eGFR 10 to 14 ml&#47;min&#41; and 424 were assigned to a late-start group &#40;eGFR 5 to 7 ml&#47;min&#41;&#46; The eGFR was determined using the Cockcroft-Gault equation&#44; after correction for body-surface area<span class="elsevierStyleSup">18</span>&#46; The MDRD equation was used for comparison&#46; Median duration of follow-up averaged 3&#46;5 years&#44; and both groups did not differ significantly with respect to pharmacologic intervention&#46; At the time of initiation&#160;of dialysis&#44; the mean eGFR&#160;was 12 ml&#47;min in the early start group and 9&#46;8 ml&#47;min in the late-start group &#40;mean difference&#44; 2&#46;2 ml&#47;min&#59; 95&#37; CI&#44; 1&#46;8 to 2&#46;6&#59; p &#60;0&#46;001&#41; using the Cockcroft-Gault equation and 9 and 7&#46;2 ml&#47;min in the early and late-start groups&#44; respectively &#40;mean difference&#44; 1&#46;8 ml&#47;min&#59; 95&#37;CI&#44; 1&#46;4 to 2&#46;2&#59; p &#60;0&#46;001&#41; utilizing the MDRD equation&#46; In the early and late-start groups&#44; 195 and 171 patients initiated renal replacement therapy with peritoneal dialysis&#46; Of all the patients&#44; 307 died during the follow-up period&#44; 152 in the early-start group and 155 in the late-start group &#40;cardiovascular death was the most common event&#41;&#46; There was no significant difference in survival between the two groups &#40;HR in the early-start group 1&#46;04&#58; 95&#37; CI&#44; 0&#46;83 to 1&#46;30&#59; p &#61; 0&#46;75&#41;&#46; The time of dialysis did not influence secondary events &#40;cardiovascular&#44; infectious&#41; or quality of life&#46; The conclusion from the study was that early initiation of dialysis had no significant effect on the rate of death from any cause&#46; The results of the IDEAL study do not imply that initiation of dialysis can be delayed until an estimated GFR of 5 to 7 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; 765 of patients in the late-start group had to initiate dialysis when the GFR was above 5 to 7 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; due to the development of uremia and fluid overload among other causes&#46; This represents a necessary protocol violation&#46; Also the mean difference of eGFR between both groups was only 2&#46;2 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#44; with six months apart before the start of dialysis&#46; The reality is that waiting to initiate dialysis until signs of uremia appear does not jeopardize the patient&#46; &#171;Early referral to a nephrologist&#44; a well organized patient-education program&#44; and careful planning before dialysis is initiated&#44; are the cornestones of such strategy&#187; as stated by Lameire&#44; et al&#46;<span class="elsevierStyleSup">19</span>&#46; The results of the study are difficult to compare with previous registry studies since it considers both eGFR and symptoms&#46; There were no reports of baseline GFR prior to the initiation of dialysis&#44; quality of life scores&#44; differences in survival outcomes between young&#44; elderly patients&#44; and types of dialysis techniques &#40;hemodialysis vs peritoneal dialysis&#41;&#46; This data echoes a previous study by Korevar&#44; et al&#46; that showed similar results&#44; differing in health-related quality of life parameters in the first 12 months of the initiation of dialysis<span class="elsevierStyleSup">20</span>&#46; In conclusion&#44; early initiation of dialysis is not associated with improved survival&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">LIMITATIONS OF THE CURENT LITERATURE</span></p><p class="elsevierStylePara">The level of evidence of the retrospective studies mentioned is II-2 &#40;based on The US Preventive Services&#160; Task force&#41;&#46; The IDEAL study probably represents a level I<span class="elsevierStyleSup">21</span>&#46;</p><p class="elsevierStylePara">Lead-time bias&#44; the interval between the start of a study and a defined event&#44; is a limitation in these studies&#46; An error in the conclusions may occur if patients are entered at different stages in the course of the illness&#46; A prolonged survival may be due to early registration of the patient&#46; In dialysis&#44; measuring survival from the start of the treatment increases apparent survival of those started with more residual renal function<span class="elsevierStyleSup">11</span>&#46; Other limitations include &#160;age &#40;older men started at higher GFR&#41; of the study population<span class="elsevierStyleSup">22</span>&#44; sex &#40;with lower survival rates in female patients&#41; and comorbidities like diabetes mellitus&#44; all of which may influence survival&#46; The type of dialysis modality may also influence outcomes&#44; with peritoneal dialysis showing better outcomes initially<span class="elsevierStyleSup">23</span>&#46;<span class="elsevierStyleSup"> </span>Incomplete information should also be considered because of primary data errors at the time of dialysis&#46; Another important factor is the non-standardized methods of measuring serum creatinine&#44; and the subsequent calculated results of eGFR&#46; The MDRD formula has not been validated in patients with advanced renal failure&#46; For example&#44; the four-variable MDRD equation was developed from non-Asian subjects&#44; and it may hamper results in some studies<span class="elsevierStyleSup">24</span>&#46; Additionally&#44; previous data from USRDS showed that very ill patients were started on dialysis at higher GFR as estimated by MDRD formulas&#46; The result was a spurious association of malnutrition with higher MDRD GFR due to low creatinine production&#44; which can lead to an erroneous interpretation of the effect of timing of dialysis on mortality<span class="elsevierStyleSup">12</span>&#46; Different confounding variables&#44; similar to those listed above&#44; should be considered in order to clearly interpret the present data&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">CONCLUSIONS</span></p><p class="elsevierStylePara">The optimal time for initiation of chronic dialysis remains unknown&#46; There is a trend in the nephrology literature toward earlier initiation of dialysis<span class="elsevierStyleSup">25</span>&#46; However&#44; prospective data that could guide physicians are not available&#46; Dialysis has many side effects&#44; and it was not possible to predict that starting dialysis earlier failed to improve survival&#46; Previous studies have been confounded by lead-time bias&#46; If early initiation of dialysis did improve survival&#44; then the effect would need to be sufficiently large to justify its use for patients&#44; and for healthcare funding&#46; The practice of earlier initiation of dialysis for ESRD has enormous personal&#44; social and economic implications&#44; with no survival advantage&#46; The latest IDEAL study corroborated the need to reconsider early initiation&#44; except in situations of failed attempts to control volume and electrolyte abnormalities related to uremic conditions&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">KEY CONCEPTS</span></p><p class="elsevierStylePara">1&#46; There has been an increased incidence of early initiation of dialysis in the last ten years in the ESKD U&#46;S&#46; population&#46;</p><p class="elsevierStylePara">2&#46; The early initiation of renal replacement therapy &#40;glomerular filtration rate below 10 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#41;&#44; was based on retrospective studies that did included residual renal function as a confounding factor&#46;</p><p class="elsevierStylePara">3&#46; Early initiation of dialysis with elevated GFR&#8217;s does not improve survival except in the presence of comorbidities and signs of uremia&#46;</p><p class="elsevierStylePara"><a href="grande&#47;10795&#95;108&#95;14715&#95;en&#95;10795&#95;t1&#46;jpg" class="elsevierStyleCrossRefs"><img src="10795_108_14715_en_10795_t1.jpg" alt="Survival outcomes in early versus late initiation of dialysis "></img></a></p><p class="elsevierStylePara">Table 1&#46; Survival outcomes in early versus late initiation of dialysis </p>"
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        "resumen" => "<p class="elsevierStylePara">Despite the widespread use of chronic dialysis&#44; there remains a lack of consensus about the optimal time for initiation of renal replacement therapy&#46; Recommendations from the National Kidney Foundation Kidney Disease Outcome Quality Initiative are generally used as the guideline&#46; This has resulted in a trend in the past decade toward earlier initiation of dialysis&#44; especially in the elderly&#46; The associated burden of comorbidities in the elderly population has resulted in greatly reduced survival outcomes&#46; Here&#44; the data obtained from retrospective cohort studies have been corroborated with a recent randomized control trial conducted in Australia and New Zealand &#40;IDEAL study&#41;&#46; There are limitations to consider from the IDEAL study that originate from different confounding factors that intervene in the test population&#46; The present paper is an evidence-based review of the literature&#44; focusing on diminution of survival outcomes following the early initiation of dialysis&#46;</p>"
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        "resumen" => "<p class="elsevierStylePara"><span class="elsevierStyleItalic">A pesar de que el uso de la di&#225;lisis cr&#243;nica est&#225; muy extendido&#44; a&#250;n no existe consenso en cuanto a cu&#225;l es el mejor momento para comenzar el tratamiento renal sustitutivo&#44; por lo que se suelen utilizar como referencia las recomendaciones de la Iniciativa para la Calidad de los Resultados de la Insuficiencia Renal de la Fundaci&#243;n Nacional del Ri&#241;&#243;n &#40;NKF-KDOQI&#41;&#46; Esto ha provocado que durante la &#250;ltima d&#233;cada hay surgido una tendencia a iniciar la di&#225;lisis antes&#44; especialmente en el caso de las personas de edad avanzada&#44; lo que ha conllevado a una reducci&#243;n considerable de las tasas de supervivencia&#44; debido a la mayor carga de comorbilidades que sufre esta poblaci&#243;n&#46; Los datos de estudios de cohorte retrospectivos han sido corroborados por el ensayo controlado aleatorizado que se ha realizado recientemente en Australia y Nueva Zelanda&#44; el estudio IDEAL&#46; Este estudio tiene ciertas limitaciones&#44; ya que existen diferentes factores de confusi&#243;n que afectan a la poblaci&#243;n estudiada&#46; Nuestro trabajo es una revisi&#243;n basada en la evidencia que se centra en la reducci&#243;n de las tasas de supervivencia que se ha producido con el inicio temprano de la di&#225;lisis&#46;</span></p>"
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Repercussions of early versus late initiation of dialysis
Repercusiones del inicio temprano y del inicio tardío de la diálisis
L.M.. Ortegaa, A.. Nayera
a Division of Nephrology and Hypertension, University of Miami Miller School of Medicine, Miami, Florida, USA,
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    "textoCompleto" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">INTRODUCTION</span></p><p class="elsevierStylePara">Hemodialysis therapy assists patients in the management of uremia and volume control through diffusion and convection&#46; This approach purports to lead to decreased morbidity and mortality&#44; as well as to improve the quality of life&#46; In order to improve survival&#44; the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative &#40;NKF-DOQUI&#41; recommended that dialysis be initiated when weekly renal&#160; KT&#47;V<span class="elsevierStyleInf">urea</span>&#160;decreased to less than 2&#46;0&#46; This approximated an estimated glomerular filtration rate &#40;e GFR&#41; of 10&#46;5 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#44; unless 3 of the following criteria were fulfilled&#58; <span class="elsevierStyleItalic">1&#41;</span> stable or increased edema-free body weight&#59; <span class="elsevierStyleItalic">2&#41;</span> no evidence of malnutrition &#40;normalized protein equivalent of total nitrogen appearance &#62;0&#46;8&#41;&#44; and <span class="elsevierStyleItalic">3&#41;</span> absence of clinical symptoms and signs due to uremia<span class="elsevierStyleSup">1</span>&#46; <span class="elsevierStyleItalic">This was based on NKF-DOQUI peritoneal dialysis guidelines because of the lack of outcome studies evaluating residual renal function in hemodialysis&#46;</span><span class="elsevierStyleBold"> </span>Recommendations that were updated in 2006 with initiation of dialysis when the eGFR was &#60;15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> as predicated by a previous evaluation of benefits and risks by the nephrologist&#44; and with eGFR &#62;15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> in symptomatic patients&#46; European guidelines recommended that dialysis should be instituted<span class="elsevierStyleSup">2</span> when the eGFR is &#60;15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; This recommendations were supported by data from the Canada and United States study &#40;CANUSA study&#41; of continuous ambulatory peritoneal dialysis<span class="elsevierStyleSup">3</span>&#46;<span class="elsevierStyleSup">&#160;</span>Later refuted by the ADEquacy of PD in MEXico &#40;ADEMEX&#41; and Hemodialysis &#40;HEMO&#41; studies<span class="elsevierStyleSup">4&#44;5</span>&#46;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</p><p class="elsevierStylePara">Data selected from the United States Renal Data System &#40;USRDS&#41; demonstrated an increase in the frequency of patients initiating dialysis &#40;hemo and peritoneal dialysis&#41;<span class="elsevierStyleSup">6</span>&#44; with estimated eGFR above 10 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; In 2005&#44; 30&#37; of patients started dialysis at eGFR values of 10-14&#46;9 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2 </span>&#44; and 15&#37; at eGFR greater than 15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2 </span>&#40;compared&#160;to 15&#37; and 4&#37; respectively&#44; in 1996&#41;&#46; The frequency of eGFR &#62;10 mlL&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> increased to 54&#37; from 25&#37; in 1996&#44; especially in patients over the age of 75 years at the time of initiation of dialysis<span class="elsevierStyleSup">6</span>&#46; The individuals who recommended the increased frequency of early initiation relied heavily on eGFR equations&#44; financial reasons&#44; and comorbidities &#40;end-stage renal disease &#40;ESRD&#41; due to diabetes &#40;43&#37; in 1996 and 44&#46;2&#37; in 2005&#41;&#46; This approach burdened the Medicare-ESRD program with 18&#44;076 more patients &#40;started&#160; in 2005&#41;&#44; at an approximate additional annual cost of &#36;641 million in 2006<span class="elsevierStyleSup">7</span>&#46;</p><p class="elsevierStylePara">Therefore&#44; the goal of this review is to evaluate current literature which describes observational and retrospective studies that were conducted to compare early or late initiation of dialysis&#44; and the influence of these practices in survival in the ESRD population&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">EARLY OR LATE INITIATION OF DIALYSIS </span>&#40;table 1&#41;</p><p class="elsevierStylePara">The suggestion that early initiation of dialysis was beneficial was first given support by Bonomini&#44; et al&#46;<span class="elsevierStyleSup">8</span>&#44; showing a 12 year survival of 77&#37; in 82 patients who started dialysis early &#40;mean creatinine clearance CrCl of 12&#46;9 ml&#47;min&#41;&#46; These results were compared with 51&#37; in 308 patients who started late &#40;CrCl of 2&#46;1 to 4&#46;8 ml&#47;min&#41;&#46; However&#44; the study did not adjust for age or other comorbidities&#46;</p><p class="elsevierStylePara">A study published by Fink&#44; et al&#46;<span class="elsevierStyleSup">9</span> with patients who initiated dialysis between April 1995 and December 1996&#44; analyzed data obtained from the Health Care Financing Administration &#40;HCFA&#41; Form 2728&#46; Creatinine levels correlated inversely with mortality risk&#46; The relationship sustained after transformation into eGFR&#44; multivariate adjustment for confounders resulted in a relative risk &#61; 0&#46;96&#59; p<span class="elsevierStyleItalic"> </span>&#60;0&#46;0001&#46;&#160;&#160;&#160;&#160;&#160;&#160;</p><p class="elsevierStylePara">In the Netherlands&#44; Korevaar&#44; et al&#46;<span class="elsevierStyleSup">10</span> investigated 253 patients starting dialysis between January 1997 and May 1999 as part of a prospective multicentre study that evaluated mortality at initiation of dialysis in late and early patients&#46; The mean follow-up time was 33-34 months&#46; Thirty-seven percent were late starters with a GFR between 4-9&#160;mL&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; There was an increased mortality risk for late starters&#44; although not statistically significant &#40;adjusted HR 1&#46;66&#44; 95&#37; confidence interval &#40;CI 0&#46;95-2&#46;89&#41;&#46; The two year survival was 75&#37; &#40;95&#37; CI&#41; in late starters&#44; and 84&#37; in early starters&#46; Traynor corroborated this data&#44; evaluating patients from the Glasgow Royal Infirmary registry&#46; He noticed a 10&#37; increased risk of hazard of death for every 1 ml&#47;min extra creatinine clearance at start of dialysis<span class="elsevierStyleSup">11</span>&#46;</p><p class="elsevierStylePara">Retrospective studies have described an increased risk of death in patients <span class="elsevierStyleItalic">starting dialysis at higher glomerular filtration rates&#46;</span></p><p class="elsevierStylePara">Beddhu&#44; et al&#46;<span class="elsevierStyleSup">12</span>&#44; analyzed patients from the United States Renal Data System &#40;USRDS&#41; Dialysis Morbidity Mortality Wave Study II to determine the associations of modification of diet in renal disease &#40;MDRD&#41; GFR formulation&#44; and also measured CrCl at the initiation of dialysis with subsequent mortality&#46; Higher eGFR at initiation of dialysis was associated with increased risk of death&#46; There were divergent results between MDRD GFR and CrCl calculations attributed to erroneous GFR estimations by the MDRD formula&#46;</p><p class="elsevierStylePara">In a later study&#44; Kazmi&#44; et al&#46;<span class="elsevierStyleSup">13</span> evaluated data from the Center for Medicare &#38; Medicaid Services between 1996 and 1999&#44; linking three incident dialysis populations and the risk of death based on GFR at initiation of dialysis&#46; After adjusting for all covariates&#44; the increased risk of death in the general population age 18&#43; years was 42&#37; with GFR &#62;10 mL&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#160;compared&#160;with GFR &#60;5 mL&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; Patients with ages 67&#43; years&#44; and a &#171;low risk&#187; subgroup without comorbidities &#40;diabetes&#44; heart failure&#44; atherosclerotic heart disease&#41; had an adjusted increased risk of 25&#37; and 39&#37;&#44; respectively&#46;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</p><p class="elsevierStylePara">The outcomes discussed above correlated with &#160;three recently published studies&#46; In the first&#44; Wright&#44; et al&#46;<span class="elsevierStyleSup">14</span>&#44; carried out a retrospective analyses of patients entering the USRDS from January 1995 to September 2006&#46; Of the total incident population &#40;896&#44;546&#41;&#44; 99&#44;231 patients had an early start &#40;eGFR &#62;15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#41; and 113&#44;510 had late start &#40;eGFR&#8804; 5 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#41;&#46; Late starters had a 12&#37; reduced risk in mortality &#40;HR&#44; 0&#46;88&#59; 95&#37; CI 0&#46;84 to 0&#46;92&#59; p &#60;0&#46;001<span class="elsevierStyleItalic">&#41;</span> whereas there was an 44&#37; increase in mortality risk associated with early starts&#58; eGFR &#62;10 to 15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2 </span>&#40;HR&#44; 1&#46;15&#59; 95&#37; CI 1&#46;15 to 1&#46;16&#59; p &#60;0&#46;001&#41; or an eGFR &#62;15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> &#40;HR&#44; 1&#46;44&#59; 95&#37; CI&#44; 1&#46;43 to 1&#46;45&#59; p &#60;0&#46;001&#41;&#46;</p><p class="elsevierStylePara">A second study by Rosansky&#44; et al&#46;<span class="elsevierStyleSup">15</span> investigated an incident ESRD population from 1996 through 2006&#44; using the Center for Medicare and Medicaid Services 2728 form&#46; The goal was to determine if early initiation had survival benefit&#46; Mortality was 20&#46;1&#37; in the early-start and 6&#46;8&#37; in the late-start groups&#46; There was a 3&#46;5-fold greater mortality with an eGFR of 15 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2 </span>at the initiation of dialysis compared to an eGFR lower than 5 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; Male sex&#44; African American race and body mass index &#40;BMI&#41; &#60;25&#44; had a negative effect on survival&#46; High levels of hemoglobin &#40;10&#46;2 g&#47;dl&#41;&#44; Asian race&#44; and PCKD or glomerular disease had a positive effect on survival&#46;</p><p class="elsevierStylePara">A third retrospective study by Clark&#44; et al&#46;<span class="elsevierStyleSup">16</span> in Canada identified 25&#44;910 patients&#44; from the Canadian Organ Replacement Register&#44; between 2001 and 2007&#46; Of those patients&#44; 32&#46;6&#37; initiated dialysis at an eGFR above 10&#46;5 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2&#160;</span>and 67&#46;4&#37; at an eGFR of 10&#46;5 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2 </span>or less &#40;mean eGFR 15&#46;5&#44; Standard Deviation &#91;SD&#93; 7&#46;7 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> early initiation&#44; 7&#46;1 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> &#44; SD 2&#46;0&#44; late initiation&#41;&#46; Median follow-up 2&#46;3 years&#46; The early group had higher incidence of coronary artery disease&#44; peripheral vascular and&#44; cerebrovascular disease&#44; diabetes mellitus&#44; and lung disease &#40;early group&#58; 44&#46;9&#37;&#44; 26&#37;&#44; 16&#46;8&#37;&#44; 52&#46;7&#37;&#44; 16&#46;8&#37;&#59; late group&#58; 31&#46;3&#37;&#44; 18&#37;&#44; 13&#46;2&#37;&#44; 43&#46;4&#37;&#44; 12&#46;5&#37;&#44; respectively&#41;&#46; The adjusted mortality differential between patients with early and late initiation narrowed after one year of follow-up&#44; but the mortality rates never converged&#44; and the differential began to widen again after two years in the Kaplan-Meier survival curves&#46; After three years&#44; there were 27 more deaths per 1&#44;000 patient-years in the group with early initiation&#46;</p><p class="elsevierStylePara">The literature presented here compared early retrospective studies that associated patient survival with early initiation of dialysis&#44; in disagreement with later data&#46; The concern was the higher relative mortality rate especially with patients starting at eGFR of 10 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span> or higher&#46; A possible mechanism might include&#58; recurrent episodes of myocardial ischemia and &#171;stunning myocardium&#187;&#44; with fixed systolic dysfunction directly related to ultrafiltration and hypotensive episodes&#46; Since most of the information was retrospective in nature&#44; it is subject to limitations in interpretation of the different covariants that are important in these studies&#46; In order to obtain a clearer picture it would be necessary to carry out randomized control trials&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">THE &#171;IDEAL&#187; STUDY</span></p><p class="elsevierStylePara">The Initiating Dialysis Early and Late study&#160;&#40;IDEAL&#41;<span class="elsevierStyleSup">17 </span>was designed as a randomized controlled trial to determine whether initiating dialysis early in individuals with stage V chronic kidney disease reduced the rate of death from any cause&#46; Secondary aims were to determine whether early initiation of dialysis was associated with reduction in cardiovascular and infectious events&#44; and in complications of dialysis&#46; Between July 2000 and November 2008&#44; 828 patients were recruited at 32 centers in Australia and New Zealand&#46; From these individuals&#44; 404 patients were randomly assigned to an early-start group &#40;eGFR 10 to 14 ml&#47;min&#41; and 424 were assigned to a late-start group &#40;eGFR 5 to 7 ml&#47;min&#41;&#46; The eGFR was determined using the Cockcroft-Gault equation&#44; after correction for body-surface area<span class="elsevierStyleSup">18</span>&#46; The MDRD equation was used for comparison&#46; Median duration of follow-up averaged 3&#46;5 years&#44; and both groups did not differ significantly with respect to pharmacologic intervention&#46; At the time of initiation&#160;of dialysis&#44; the mean eGFR&#160;was 12 ml&#47;min in the early start group and 9&#46;8 ml&#47;min in the late-start group &#40;mean difference&#44; 2&#46;2 ml&#47;min&#59; 95&#37; CI&#44; 1&#46;8 to 2&#46;6&#59; p &#60;0&#46;001&#41; using the Cockcroft-Gault equation and 9 and 7&#46;2 ml&#47;min in the early and late-start groups&#44; respectively &#40;mean difference&#44; 1&#46;8 ml&#47;min&#59; 95&#37;CI&#44; 1&#46;4 to 2&#46;2&#59; p &#60;0&#46;001&#41; utilizing the MDRD equation&#46; In the early and late-start groups&#44; 195 and 171 patients initiated renal replacement therapy with peritoneal dialysis&#46; Of all the patients&#44; 307 died during the follow-up period&#44; 152 in the early-start group and 155 in the late-start group &#40;cardiovascular death was the most common event&#41;&#46; There was no significant difference in survival between the two groups &#40;HR in the early-start group 1&#46;04&#58; 95&#37; CI&#44; 0&#46;83 to 1&#46;30&#59; p &#61; 0&#46;75&#41;&#46; The time of dialysis did not influence secondary events &#40;cardiovascular&#44; infectious&#41; or quality of life&#46; The conclusion from the study was that early initiation of dialysis had no significant effect on the rate of death from any cause&#46; The results of the IDEAL study do not imply that initiation of dialysis can be delayed until an estimated GFR of 5 to 7 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; 765 of patients in the late-start group had to initiate dialysis when the GFR was above 5 to 7 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#46; due to the development of uremia and fluid overload among other causes&#46; This represents a necessary protocol violation&#46; Also the mean difference of eGFR between both groups was only 2&#46;2 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#44; with six months apart before the start of dialysis&#46; The reality is that waiting to initiate dialysis until signs of uremia appear does not jeopardize the patient&#46; &#171;Early referral to a nephrologist&#44; a well organized patient-education program&#44; and careful planning before dialysis is initiated&#44; are the cornestones of such strategy&#187; as stated by Lameire&#44; et al&#46;<span class="elsevierStyleSup">19</span>&#46; The results of the study are difficult to compare with previous registry studies since it considers both eGFR and symptoms&#46; There were no reports of baseline GFR prior to the initiation of dialysis&#44; quality of life scores&#44; differences in survival outcomes between young&#44; elderly patients&#44; and types of dialysis techniques &#40;hemodialysis vs peritoneal dialysis&#41;&#46; This data echoes a previous study by Korevar&#44; et al&#46; that showed similar results&#44; differing in health-related quality of life parameters in the first 12 months of the initiation of dialysis<span class="elsevierStyleSup">20</span>&#46; In conclusion&#44; early initiation of dialysis is not associated with improved survival&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">LIMITATIONS OF THE CURENT LITERATURE</span></p><p class="elsevierStylePara">The level of evidence of the retrospective studies mentioned is II-2 &#40;based on The US Preventive Services&#160; Task force&#41;&#46; The IDEAL study probably represents a level I<span class="elsevierStyleSup">21</span>&#46;</p><p class="elsevierStylePara">Lead-time bias&#44; the interval between the start of a study and a defined event&#44; is a limitation in these studies&#46; An error in the conclusions may occur if patients are entered at different stages in the course of the illness&#46; A prolonged survival may be due to early registration of the patient&#46; In dialysis&#44; measuring survival from the start of the treatment increases apparent survival of those started with more residual renal function<span class="elsevierStyleSup">11</span>&#46; Other limitations include &#160;age &#40;older men started at higher GFR&#41; of the study population<span class="elsevierStyleSup">22</span>&#44; sex &#40;with lower survival rates in female patients&#41; and comorbidities like diabetes mellitus&#44; all of which may influence survival&#46; The type of dialysis modality may also influence outcomes&#44; with peritoneal dialysis showing better outcomes initially<span class="elsevierStyleSup">23</span>&#46;<span class="elsevierStyleSup"> </span>Incomplete information should also be considered because of primary data errors at the time of dialysis&#46; Another important factor is the non-standardized methods of measuring serum creatinine&#44; and the subsequent calculated results of eGFR&#46; The MDRD formula has not been validated in patients with advanced renal failure&#46; For example&#44; the four-variable MDRD equation was developed from non-Asian subjects&#44; and it may hamper results in some studies<span class="elsevierStyleSup">24</span>&#46; Additionally&#44; previous data from USRDS showed that very ill patients were started on dialysis at higher GFR as estimated by MDRD formulas&#46; The result was a spurious association of malnutrition with higher MDRD GFR due to low creatinine production&#44; which can lead to an erroneous interpretation of the effect of timing of dialysis on mortality<span class="elsevierStyleSup">12</span>&#46; Different confounding variables&#44; similar to those listed above&#44; should be considered in order to clearly interpret the present data&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">CONCLUSIONS</span></p><p class="elsevierStylePara">The optimal time for initiation of chronic dialysis remains unknown&#46; There is a trend in the nephrology literature toward earlier initiation of dialysis<span class="elsevierStyleSup">25</span>&#46; However&#44; prospective data that could guide physicians are not available&#46; Dialysis has many side effects&#44; and it was not possible to predict that starting dialysis earlier failed to improve survival&#46; Previous studies have been confounded by lead-time bias&#46; If early initiation of dialysis did improve survival&#44; then the effect would need to be sufficiently large to justify its use for patients&#44; and for healthcare funding&#46; The practice of earlier initiation of dialysis for ESRD has enormous personal&#44; social and economic implications&#44; with no survival advantage&#46; The latest IDEAL study corroborated the need to reconsider early initiation&#44; except in situations of failed attempts to control volume and electrolyte abnormalities related to uremic conditions&#46;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">KEY CONCEPTS</span></p><p class="elsevierStylePara">1&#46; There has been an increased incidence of early initiation of dialysis in the last ten years in the ESKD U&#46;S&#46; population&#46;</p><p class="elsevierStylePara">2&#46; The early initiation of renal replacement therapy &#40;glomerular filtration rate below 10 ml&#47;min&#47;1&#46;73 m<span class="elsevierStyleSup">2</span>&#41;&#44; was based on retrospective studies that did included residual renal function as a confounding factor&#46;</p><p class="elsevierStylePara">3&#46; Early initiation of dialysis with elevated GFR&#8217;s does not improve survival except in the presence of comorbidities and signs of uremia&#46;</p><p class="elsevierStylePara"><a href="grande&#47;10795&#95;108&#95;14715&#95;en&#95;10795&#95;t1&#46;jpg" class="elsevierStyleCrossRefs"><img src="10795_108_14715_en_10795_t1.jpg" alt="Survival outcomes in early versus late initiation of dialysis "></img></a></p><p class="elsevierStylePara">Table 1&#46; Survival outcomes in early versus late initiation of dialysis </p>"
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        "resumen" => "<p class="elsevierStylePara">Despite the widespread use of chronic dialysis&#44; there remains a lack of consensus about the optimal time for initiation of renal replacement therapy&#46; Recommendations from the National Kidney Foundation Kidney Disease Outcome Quality Initiative are generally used as the guideline&#46; This has resulted in a trend in the past decade toward earlier initiation of dialysis&#44; especially in the elderly&#46; The associated burden of comorbidities in the elderly population has resulted in greatly reduced survival outcomes&#46; Here&#44; the data obtained from retrospective cohort studies have been corroborated with a recent randomized control trial conducted in Australia and New Zealand &#40;IDEAL study&#41;&#46; There are limitations to consider from the IDEAL study that originate from different confounding factors that intervene in the test population&#46; The present paper is an evidence-based review of the literature&#44; focusing on diminution of survival outcomes following the early initiation of dialysis&#46;</p>"
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        "resumen" => "<p class="elsevierStylePara"><span class="elsevierStyleItalic">A pesar de que el uso de la di&#225;lisis cr&#243;nica est&#225; muy extendido&#44; a&#250;n no existe consenso en cuanto a cu&#225;l es el mejor momento para comenzar el tratamiento renal sustitutivo&#44; por lo que se suelen utilizar como referencia las recomendaciones de la Iniciativa para la Calidad de los Resultados de la Insuficiencia Renal de la Fundaci&#243;n Nacional del Ri&#241;&#243;n &#40;NKF-KDOQI&#41;&#46; Esto ha provocado que durante la &#250;ltima d&#233;cada hay surgido una tendencia a iniciar la di&#225;lisis antes&#44; especialmente en el caso de las personas de edad avanzada&#44; lo que ha conllevado a una reducci&#243;n considerable de las tasas de supervivencia&#44; debido a la mayor carga de comorbilidades que sufre esta poblaci&#243;n&#46; Los datos de estudios de cohorte retrospectivos han sido corroborados por el ensayo controlado aleatorizado que se ha realizado recientemente en Australia y Nueva Zelanda&#44; el estudio IDEAL&#46; Este estudio tiene ciertas limitaciones&#44; ya que existen diferentes factores de confusi&#243;n que afectan a la poblaci&#243;n estudiada&#46; Nuestro trabajo es una revisi&#243;n basada en la evidencia que se centra en la reducci&#243;n de las tasas de supervivencia que se ha producido con el inicio temprano de la di&#225;lisis&#46;</span></p>"
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                  "referenciaCompleta" => "National Kidney Foundation. NKF/DOQUI Clinical Practice Guidelines for Peritoneal Dialysis Adequacy: Update 2000. Am J Kidney Dis 2001;37(Suppl 1):S65-S136. <a href="http://www.ncbi.nlm.nih.gov/pubmed/11229968" target="_blank">[Pubmed]</a>"
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