A randomized clinical trial of continuous versus intermittent dialysis for acute renal failure

A randomized clinical trial of continuous versus intermittent dialysis for acute renal failure
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DOI:
10.1046/j.1523-1755.2001.0600031154.x
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发表时间:
2001-09-01
影响因子:
19.6
通讯作者:
Kaplan, RM
Kaplan, RM
中科院分区:
医学1区
文献类型:
--
作者:
Mehta, RL;McDonald, B;Kaplan, RM

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背景重症患者中需要透析的急性肾衰竭(ARF)与50%至80%的住院死亡率相关。肾脏替代治疗的全球标准是间歇性血液透析(IHD)。连续性血液透析和血液滤过技术最近已成为替代模式。这两种疗法尚未直接比较。进行了一项多中心、随机、对照试验,比较了两种透析方式(IHD与连续性血液透析滤过)在重症监护室(ICU)治疗ARF的效果。166例患者接受了随机化。主要观察指标为ICU和住院死亡率、住院时间和肾功能恢复情况。使用意向治疗分析,ICU和住院死亡率分别为50.6%和56.6%。与间歇性透析相比,连续治疗增加了ICU(59.5 vs. 41.5%,P < 0.02)和院内(65.5 vs. 47.6%,P < 0.02)死亡率。从肾脏科会诊开始的ICU中位住院时间为16.5天,在34.9%的患者中观察到肾功能完全恢复,无显著组间差异。尽管随机分组,但两组之间在与死亡率独立相关的几个协变量方面存在显著差异,包括性别、肝衰竭、APACHE II和III评分以及衰竭器官系统的数量,在每种情况下都偏向于间歇性透析组。使用逻辑回归校正分组不平衡,与连续治疗相关的死亡几率为1.3(95%CI,0.6 - 2.7,P = NS)。对随机化过程的详细调查未能解释患者分配的显著差异。ARF替代透析方式的随机对照试验是可行的。尽管连续性技术具有潜在优势,但本研究未提供连续性血液透析滤过与IHD相比的生存获益证据。本研究未控制其他重大临床决策或其他支持性管理策略,这些策略具有广泛的可变性(例如,营养支持、血流动力学支持、启动时间和透析剂量),可能会对ARF结局产生实质性影响。需要对护理的几个方面或超大样本量进行标准化,以最佳方式回答本研究最初提出的问题。
Background. Acute renal failure (ARF) requiring dialysis in critically ill patients is associated with an in-hospital mortality rate of 50 to 80%. The worldwide standard for renal replacement therapy is intermittent hemodialysis (IHD). Continuous hemodialysis and hemofiltration techniques have recently emerged as alternative modalities. These two therapies have not been directly compared.Methods. A multicenter, randomized, controlled trial was conducted comparing two dialysis modalities (IHD vs. continuous hemodiafiltration) for the treatment of ARF in the intensive care unit (ICU). One hundred sixty-six patients were randomized. Principal outcome measures were ICU and hospital mortality, length of stay, and recovery of renal function.Results. Using intention-to-treat analysis, the overall ICU and in-hospital mortalities were 50.6 and 56.6%, respectively. Continuous therapy was associated with an increase in ICU (59.5 vs. 41.5%, P < 0.02) and in-hospital (65.5 vs. 47.6%, P < 0.02) mortality relative to intermittent dialysis. Median ICU length of stay from the time of nephrology consultation was 16.5 days, and complete recovery of renal function was observed in 34.9% of patients, with no significant group differences. Despite randomization, there were significant differences between the groups in several covariates independently associated with mortality, including gender, hepatic failure, APACHE Il and III scores, and the number of failed organ systems, in each instance biased in favor of the intermittent dialysis group. Using logistic regression to adjust for the imbalances in group assignment, the odds of death associated with continuous therapy was 1.3 (95% Cl, 0.6 to 2.7, P = NS). A detailed investigation of the randomization process failed to explain the marked differences in patient assignment.Conclusions. A randomized controlled trial of alternative dialysis modalities in ARF is feasible. Despite the potential advantages of continuous techniques, this study provides no evidence of a survival benefit of continuous hemodiafiltration compared with IHD. This study did not control for other major clinical decisions or other supportive management strategies that are widely variable (for example, nutrition support, hemodynamic support, timing of initiation, and dose of dialysis) and might materially influence outcomes in ARF. Standardization of several aspects of care or extremely large sample sizes will be required to answer optimally the questions originally posed by this investigation.