间歇性或连续性肾脏替代治疗在急性肾损伤中的应用
完整摘要 · 中文译文
背景：危重症患者急性肾损伤的肾脏替代治疗首选方法仍不确定。 方法：在这项多中心、开放标签、非劣效性试验中，我们将有肾脏替代治疗指征的急性肾损伤危重症成年患者随机分配，接受间歇性血液透析或连续性肾脏替代治疗作为初始治疗。主要结局为至第90天时发生的重大不良肾脏事件——定义为死亡、依赖肾脏替代治疗，或血清肌酐浓度较基线值升高超过25%。 结果：在序贯中期分析显示间歇性血液透析相比连续性肾脏替代治疗持续出现更高的死亡风险信号后，试验提前终止。共有554例患者接受了随机分组，其中272例被分配接受间歇性血液透析，282例接受连续性肾脏替代治疗；535例患者（间歇组260例，连续性组275例）被纳入意向性治疗人群。在第90天时，间歇组有203例患者（78.1%）发生主要不良肾脏事件，连续性组有197例患者（71.6%）发生主要不良肾脏事件（校正后绝对风险差为6.28个百分点；95%置信区间[CI]为-1.22至13.79）。第90天时，间歇组有164例患者（63.1%）死亡，连续性组有147例患者（53.5%）死亡。第90天时的Kaplan-Meier死亡估计分别为63.3%和53.6%（风险比为1.30；95%CI为1.04至1.63）。可能与急性肾损伤或肾脏替代治疗相关的最常见并发症是低血压，间歇组有179例患者（68.8%）发生，连续性组有183例患者（66.5%）发生。 结论：在具有肾脏替代治疗指征的急性肾损伤危重患者中，就至第90天的主要不良肾脏事件而言，以间歇性血液透析作为初始治疗方式未显示不劣于连续性肾脏替代治疗，并且与更高的死亡率相关。（由法国卫生部资助；ICRAKI ClinicalTrials.gov注册号，NCT06032884。）
完整摘要 · 英文原文
BACKGROUND: The preferred method of renal-replacement therapy for acute kidney injury in critically ill patients remains uncertain. METHODS: In this multicenter, open-label, noninferiority trial, we randomly assigned critically ill adults with acute kidney injury who had indications for renal-replacement therapy to undergo intermittent hemodialysis or continuous renal-replacement therapy as the initial treatment. The primary outcome was a major adverse kidney event - defined as death, dependence on renal-replacement therapy, or a serum creatinine concentration more than 25% above the baseline value - by day 90. RESULTS: The trial was stopped early after sequential interim analyses showed a sustained signal of higher mortality with intermittent hemodialysis than with continuous renal-replacement therapy. A total of 554 patients underwent randomization, with 272 patients assigned to undergo intermittent hemodialysis and 282 to undergo continuous renal-replacement therapy; 535 patients (260 in the intermittent group and 275 in the continuous group) were included in the intention-to-treat population. A major adverse kidney event occurred by day 90 in 203 patients (78.1%) in the intermittent group and in 197 patients (71.6%) in the continuous group (adjusted absolute risk difference, 6.28 percentage points; 95% confidence interval [CI], -1.22 to 13.79). Death by day 90 occurred in 164 patients (63.1%) and in 147 patients (53.5%), respectively. Kaplan-Meier mortality estimates at day 90 were 63.3% and 53.6% (hazard ratio, 1.30; 95% CI, 1.04 to 1.63). The most common complication potentially related to acute kidney injury or renal-replacement therapy was hypotension, which occurred in 179 patients (68.8%) in the intermittent group and in 183 patients (66.5%) in the continuous group. CONCLUSIONS: Among critically ill patients with acute kidney injury who had indications for renal-replacement therapy, intermittent hemodialysis as the initial treatment approach was not shown to be noninferior to continuous renal-replacement therapy with respect to major adverse kidney events by day 90 and was associated with higher mortality. (Funded by the French Ministry of Health; ICRAKI ClinicalTrials.gov number, NCT06032884.).