A Randomized, Controlled Trial of Early versus Late Initiation of Dialysis
A Randomized, Controlled Trial of Early versus Late Initiation of Dialysis
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DOI：
10.1056/nejmoa1000552
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发表时间：
2010-08-12
影响因子：
158.5
通讯作者：
Pollock, Carol A.
中科院分区：
文献类型：
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作者：
Cooper, Bruce A.;Branley, Pauline;Pollock, Carol A.
背景在临床实践中，V期慢性肾脏病患者开始维持性透析的时间有相当大的差异，全球趋势是早期开始。这项研究在澳大利亚和新西兰的32个中心进行，我们研究了开始维持性透析的时间是否影响慢性肾脏病患者的生存率。方法我们随机分配了18岁或以上的进行性慢性肾脏病患者，估计肾小球滤过率（GFR）在10.0和15.0 ml/min/1.73 m2之间。当估计的GFR为10.0 - 14.0 ml/min（早期开始）或估计的GFR为5.0 - 7.0 ml/min（晚期开始）时，体表面积（使用Cockcroft-Gault方程计算）与计划开始透析之间的差值。主要结局是全因死亡。结果2000年7月至2008年11月期间，共有828名成年人平均年龄60.4岁，男性542人，女性286人; 355例糖尿病患者）接受随机分组，至开始透析的中位时间为1.80个月（95%置信区间[CI]，1.60至2.23），在早期开始组和7.40个月（95% CI，6.23至8.27），在晚期开始组。由于症状的发展，当估计的GFR高于7.0 ml/min的目标时，晚开始组中共有75.9%的患者开始透析。在中位随访3.59年期间，早期开始组404例患者中有152例（37.6%）死亡，晚期开始组424例患者中有155例（36.6%）死亡（早期开始的风险比为1.04; 95%CI为0.83 - 1.30; P = 0.75）。两组之间不良事件（心血管事件、感染或透析并发症）的发生率无显著差异。CONCLUSIONSIn this study，有计划地对V期慢性肾脏病患者早期开始透析与生存率或临床结局的改善无关。（由澳大利亚国家健康和医学研究理事会和其他机构资助;澳大利亚新西兰临床试验注册号，12609000266268。）
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.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 m(2) 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.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).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.)