A Randomized, Controlled Trial of Early versus Late Initiation of Dialysis
In this study, adults with progressive chronic kidney disease and an estimated glomerular filtration rate between 10 and 15 ml per minute per 1.73 m 2 (stage V chronic kidney disease) were randomly assigned to early or late initiation of dialysis. Early initiation of dialysis was not associated with...
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| Published in | The New England journal of medicine Vol. 363; no. 7; pp. 609 - 619 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Massachusetts Medical Society
12.08.2010
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| Subjects | |
| Online Access | Get full text |
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| Abstract | In this study, adults with progressive chronic kidney disease and an estimated glomerular filtration rate between 10 and 15 ml per minute per 1.73 m
2
(stage V chronic kidney disease) were randomly assigned to early or late initiation of dialysis. Early initiation of dialysis was not associated with an improvement in survival or clinical outcomes.
The worldwide prevalence of long-term dialysis continues to rise,
1
,
2
driven in part by strong trends toward the initiation of dialysis earlier in the natural history of chronic kidney disease than was the practice previously.
3
–
5
Traditionally, the indicators for starting dialysis were the presence of signs and symptoms of uremia in combination with the results of biochemical measurements in serum and plasma.
6
However, a number of observational cohort and case–control studies have suggested that starting dialysis early may improve patients' survival, quality of life, and capacity for employment and decrease complications.
7
–
9
Although such studies were potentially limited by . . . |
|---|---|
| AbstractList | Background In clinical practice, there is considerable variation in the timing of the initiation of maintenance dialysis for patients with stage V chronic kidney disease, with a worldwide trend toward early initiation. In this study, conducted at 32 centers in Australia and New Zealand, we examined whether the timing of the initiation of maintenance dialysis influenced survival among patients with chronic kidney disease. Methods We randomly assigned patients 18 years of age or older with progressive chronic kidney disease and an estimated glomerular filtration rate (GFR) between 10.0 and 15.0 ml per minute per 1.73 m2 of body-surface area (calculated with the use of the Cockcroft-Gault equation) to planned initiation of dialysis when the estimated GFR was 10.0 to 14.0 ml per minute (early start) or when the estimated GFR was 5.0 to 7.0 ml per minute (late start). The primary outcome was death from any cause. Results Between July 2000 and November 2008, a total of 828 adults (mean age, 60.4 years; 542 men and 286 women; 355 with diabetes) underwent randomization, with a median time to the initiation of dialysis of 1.80 months (95% confidence interval [CI], 1.60 to 2.23) in the early-start group and 7.40 months (95% CI, 6.23 to 8.27) in the late-start group. A total of 75.9% of the patients in the late-start group initiated dialysis when the estimated GFR was above the target of 7.0 ml per minute, owing to the development of symptoms. During a median follow-up period of 3.59 years, 152 of 404 patients in the early-start group (37.6%) and 155 of 424 in the late-start group (36.6%) died (hazard ratio with early initiation, 1.04; 95% CI, 0.83 to 1.30; P=0.75). There was no significant difference between the groups in the frequency of adverse events (cardiovascular events, infections, or complications of dialysis). Conclusions In this study, planned early initiation of dialysis in patients with stage V chronic kidney disease was not associated with an improvement in survival or clinical outcomes. (Funded by the National Health and Medical Research Council of Australia and others; Australian New Zealand Clinical Trials Registry number, 12609000266268 .) In clinical practice, there is considerable variation in the timing of the initiation of maintenance dialysis for patients with stage V chronic kidney disease, with a worldwide trend toward early initiation. In this study, conducted at 32 centers in Australia and New Zealand, we examined whether the timing of the initiation of maintenance dialysis influenced survival among patients with chronic kidney disease. We randomly assigned patients 18 years of age or older with progressive chronic kidney disease and an estimated glomerular filtration rate (GFR) between 10.0 and 15.0 ml per minute per 1.73 m2 of body-surface area (calculated with the use of the Cockcroft-Gault equation) to planned initiation of dialysis when the estimated GFR was 10.0 to 14.0 ml per minute (early start) or when the estimated GFR was 5.0 to 7.0 ml per minute (late start). The primary outcome was death from any cause. Between July 2000 and November 2008, a total of 828 adults (mean age, 60.4 years; 542 men and 286 women; 355 with diabetes) underwent randomization, with a median time to the initiation of dialysis of 1.80 months (95% confidence interval [CI], 1.60 to 2.23) in the early-start group and 7.40 months (95% CI, 6.23 to 8.27) in the late-start group. A total of 75.9% of the patients in the late-start group initiated dialysis when the estimated GFR was above the target of 7.0 ml per minute, owing to the development of symptoms. During a median follow-up period of 3.59 years, 152 of 404 patients in the early-start group (37.6%) and 155 of 424 in the late-start group (36.6%) died (hazard ratio with early initiation, 1.04; 95% CI, 0.83 to 1.30; P=0.75). There was no significant difference between the groups in the frequency of adverse events (cardiovascular events, infections, or complications of dialysis). In this study, planned early initiation of dialysis in patients with stage V chronic kidney disease was not associated with an improvement in survival or clinical outcomes. (Funded by the National Health and Medical Research Council of Australia and others; Australian New Zealand Clinical Trials Registry number, 12609000266268.) In clinical practice, there is considerable variation in the timing of the initiation of maintenance dialysis for patients with stage V chronic kidney disease, with a worldwide trend toward early initiation. In this study, conducted at 32 centers in Australia and New Zealand, we examined whether the timing of the initiation of maintenance dialysis influenced survival among patients with chronic kidney disease.BACKGROUNDIn clinical practice, there is considerable variation in the timing of the initiation of maintenance dialysis for patients with stage V chronic kidney disease, with a worldwide trend toward early initiation. In this study, conducted at 32 centers in Australia and New Zealand, we examined whether the timing of the initiation of maintenance dialysis influenced survival among patients with chronic kidney disease.We randomly assigned patients 18 years of age or older with progressive chronic kidney disease and an estimated glomerular filtration rate (GFR) between 10.0 and 15.0 ml per minute per 1.73 m2 of body-surface area (calculated with the use of the Cockcroft-Gault equation) to planned initiation of dialysis when the estimated GFR was 10.0 to 14.0 ml per minute (early start) or when the estimated GFR was 5.0 to 7.0 ml per minute (late start). The primary outcome was death from any cause.METHODSWe randomly assigned patients 18 years of age or older with progressive chronic kidney disease and an estimated glomerular filtration rate (GFR) between 10.0 and 15.0 ml per minute per 1.73 m2 of body-surface area (calculated with the use of the Cockcroft-Gault equation) to planned initiation of dialysis when the estimated GFR was 10.0 to 14.0 ml per minute (early start) or when the estimated GFR was 5.0 to 7.0 ml per minute (late start). The primary outcome was death from any cause.Between July 2000 and November 2008, a total of 828 adults (mean age, 60.4 years; 542 men and 286 women; 355 with diabetes) underwent randomization, with a median time to the initiation of dialysis of 1.80 months (95% confidence interval [CI], 1.60 to 2.23) in the early-start group and 7.40 months (95% CI, 6.23 to 8.27) in the late-start group. A total of 75.9% of the patients in the late-start group initiated dialysis when the estimated GFR was above the target of 7.0 ml per minute, owing to the development of symptoms. During a median follow-up period of 3.59 years, 152 of 404 patients in the early-start group (37.6%) and 155 of 424 in the late-start group (36.6%) died (hazard ratio with early initiation, 1.04; 95% CI, 0.83 to 1.30; P=0.75). There was no significant difference between the groups in the frequency of adverse events (cardiovascular events, infections, or complications of dialysis).RESULTSBetween July 2000 and November 2008, a total of 828 adults (mean age, 60.4 years; 542 men and 286 women; 355 with diabetes) underwent randomization, with a median time to the initiation of dialysis of 1.80 months (95% confidence interval [CI], 1.60 to 2.23) in the early-start group and 7.40 months (95% CI, 6.23 to 8.27) in the late-start group. A total of 75.9% of the patients in the late-start group initiated dialysis when the estimated GFR was above the target of 7.0 ml per minute, owing to the development of symptoms. During a median follow-up period of 3.59 years, 152 of 404 patients in the early-start group (37.6%) and 155 of 424 in the late-start group (36.6%) died (hazard ratio with early initiation, 1.04; 95% CI, 0.83 to 1.30; P=0.75). There was no significant difference between the groups in the frequency of adverse events (cardiovascular events, infections, or complications of dialysis).In this study, planned early initiation of dialysis in patients with stage V chronic kidney disease was not associated with an improvement in survival or clinical outcomes. (Funded by the National Health and Medical Research Council of Australia and others; Australian New Zealand Clinical Trials Registry number, 12609000266268.)CONCLUSIONSIn this study, planned early initiation of dialysis in patients with stage V chronic kidney disease was not associated with an improvement in survival or clinical outcomes. (Funded by the National Health and Medical Research Council of Australia and others; Australian New Zealand Clinical Trials Registry number, 12609000266268.) In this study, adults with progressive chronic kidney disease and an estimated glomerular filtration rate between 10 and 15 ml per minute per 1.73 m 2 (stage V chronic kidney disease) were randomly assigned to early or late initiation of dialysis. Early initiation of dialysis was not associated with an improvement in survival or clinical outcomes. The worldwide prevalence of long-term dialysis continues to rise, 1 , 2 driven in part by strong trends toward the initiation of dialysis earlier in the natural history of chronic kidney disease than was the practice previously. 3 – 5 Traditionally, the indicators for starting dialysis were the presence of signs and symptoms of uremia in combination with the results of biochemical measurements in serum and plasma. 6 However, a number of observational cohort and case–control studies have suggested that starting dialysis early may improve patients' survival, quality of life, and capacity for employment and decrease complications. 7 – 9 Although such studies were potentially limited by . . . |
| Author | Kesselhut, Joan Cooper, Bruce A Pollock, Carol A Harris, David C Harris, Anthony Tiller, David J Fraenkel, Margaret B Luxton, Grant Branley, Pauline Johnson, David W Bulfone, Liliana Li, Jing Jing Craig, Jonathan C Pilmore, Andrew Collins, John F |
| Author_xml | – sequence: 1 givenname: Bruce A surname: Cooper fullname: Cooper, Bruce A – sequence: 2 givenname: Pauline surname: Branley fullname: Branley, Pauline – sequence: 3 givenname: Liliana surname: Bulfone fullname: Bulfone, Liliana – sequence: 4 givenname: John F surname: Collins fullname: Collins, John F – sequence: 5 givenname: Jonathan C surname: Craig fullname: Craig, Jonathan C – sequence: 6 givenname: Margaret B surname: Fraenkel fullname: Fraenkel, Margaret B – sequence: 7 givenname: David C surname: Harris fullname: Harris, David C – sequence: 7 givenname: Anthony surname: Harris fullname: Harris, Anthony – sequence: 8 givenname: David W surname: Johnson fullname: Johnson, David W – sequence: 9 givenname: Joan surname: Kesselhut fullname: Kesselhut, Joan – sequence: 10 givenname: Jing Jing surname: Li fullname: Li, Jing Jing – sequence: 11 givenname: Grant surname: Luxton fullname: Luxton, Grant – sequence: 12 givenname: Andrew surname: Pilmore fullname: Pilmore, Andrew – sequence: 13 givenname: David J surname: Tiller fullname: Tiller, David J – sequence: 15 givenname: Carol A surname: Pollock fullname: Pollock, Carol A |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/20581422$$D View this record in MEDLINE/PubMed |
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| CODEN | NEJMAG |
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| ContentType | Journal Article |
| Contributor | Holloway, T Martin, A May, S Madhan, K Krum, H Johnson, D W Dawborn, J Gillies, A McIver, M Healy, H Pollock, C A Russ, G Prasad, R Panlilio, N Kerr, P Jenkins, M Chowdhury, S Elias, T Kesselhut, J Shannon, G Mantha, M Suranyi, M Gray, N A Fisher, M Parag, V Menahem, S Fraenkel, M B Milne, A Hutchison, B Brown, M Brown, F McNeil, J Dempster, J Mathew, M Langham, R Walker, R Walker, J Lonergan, M Swao, J Harris, D C Fassett, R Collins, J F Bohte, H Pitt, A Tonkin, A Helyar, J Cooper, B A Kirkland, G Pilmore, A Davis, M Irish, A Forbes, A Jose, M Bisscheroux, P Voss, D Matheson, P Wyndham, R |
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| Copyright | Copyright © 2010 Massachusetts Medical Society. All rights reserved. |
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| References | r021 r001 r023 r017 r018 r019 r013 r014 r015 Levey AS (r025) 1999; 130 Cooper BA (r016) 2004; 24 Churchill DN (r022) 1999; 10 r031 r010 r011 r012 Hakim RM (r006) 1995; 6 r030 r028 r007 r009 r002 r024 r004 Paniagua R (r020) 2002; 13 r026 r005 r027 Bonomini V (r008) 1978; 8 (r029) 2006; 48 21142541 - N Engl J Med. 2010 Dec 9;363(24):2368-9; author reply 2369-70 21142540 - N Engl J Med. 2010 Dec 9;363(24):2369; author reply 2369-70 21105913 - Semin Dial. 2010 Nov-Dec;23(6):627-9 21047844 - Evid Based Med. 2011 Apr;16(2):44-5 21142542 - N Engl J Med. 2010 Dec 9;363(24):2368; author reply 2369-70 21327943 - Internist (Berl). 2011 Mar;52(3):336-8 21079209 - Ann Intern Med. 2010 Nov 16;153(10):JC5-2 20581421 - N Engl J Med. 2010 Aug 12;363(7):678-80 21142539 - N Engl J Med. 2010 Dec 9;363(24):2369; author reply 2369-70 |
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| Snippet | In this study, adults with progressive chronic kidney disease and an estimated glomerular filtration rate between 10 and 15 ml per minute per 1.73 m
2
(stage V... In clinical practice, there is considerable variation in the timing of the initiation of maintenance dialysis for patients with stage V chronic kidney disease,... Background In clinical practice, there is considerable variation in the timing of the initiation of maintenance dialysis for patients with stage V chronic... |
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| SubjectTerms | Adult Cardiovascular Diseases - etiology Cardiovascular Diseases - mortality Clinical medicine Female Follow-Up Studies Glomerular Filtration Rate Hemodialysis Humans Infection - etiology Infection - mortality Kaplan-Meier Estimate Kidney diseases Kidney Failure, Chronic - complications Kidney Failure, Chronic - mortality Kidney Failure, Chronic - therapy Male Middle Aged Proportional Hazards Models Quality of Life Renal Dialysis - adverse effects Renal Dialysis - methods Statistical analysis Time Factors Uremia - etiology |
| Title | A Randomized, Controlled Trial of Early versus Late Initiation of Dialysis |
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