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[NEJM发表论文]:急性肾损伤开始肾脏替代治疗的时机
2020年07月18日 时讯速递, 进展交流 暂无评论

ORIGINAL ARTICLE FREE PREVIEW

Timing of Initiation of Renal-Replacement Therapy in Acute Kidney Injury

The STARRT-AKI Investigators for the Canadian Critical Care Trials Group, the Australian and New Zealand Intensive Care Society Clinical Trials Group, the United Kingdom Critical Care Research Group, the Canadian Nephrology Trials Network, and the Irish Critical Care Trials Group

N Engl J Med 2020; 383:240-251
DOI: 10.1056/NEJMoa2000741

Abstract

BACKGROUND 背景

Acute kidney injury is common in critically ill patients, many of whom receive renal-replacement therapy. However, the most effective timing for the initiation of such therapy remains uncertain.

急性肾损伤在危重病患者非常普遍,很多患者接受肾脏替代治疗。然而,开始肾脏替代治疗的最佳时机仍不明确。

METHODS 方法

We conducted a multinational, randomized, controlled trial involving critically ill patients with severe acute kidney injury. Patients were randomly assigned to receive an accelerated strategy of renal-replacement therapy (in which therapy was initiated within 12 hours after the patient had met eligibility criteria) or a standard strategy (in which renal-replacement therapy was discouraged unless conventional indications developed or acute kidney injury persisted for >72 hours). The primary outcome was death from any cause at 90 days.

我们进行了一项多国随机对照试验,纳入严重急性肾损伤的危重病患者。患者被随机分为早期肾脏替代治疗策略(患者满足入选标准12小时内开始肾脏替代治疗)或标准策略组(不鼓励进行肾脏替代治疗,除非出现传统的肾脏替代治疗适应症或急性肾损伤持续> 72小时)。主要预后指标为90天全因病死率。

RESULTS 结果

Of the 3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group). Of these patients, renal-replacement therapy was performed in 1418 (96.8%) in the accelerated-strategy group and in 903 (61.8%) in the standard-strategy group. At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P=0.92). Among survivors at 90 days, continued dependence on renal-replacement therapy was confirmed in 85 of 814 patients (10.4%) in the accelerated-strategy group and in 49 of 815 patients (6.0%) in the standard-strategy group (relative risk, 1.74; 95% CI, 1.24 to 2.43). Adverse events occurred in 346 of 1503 patients (23.0%) in the accelerated-strategy group and in 245 of 1489 patients (16.5%) in the standard-strategy group (P<0.001).

共有3019名患者接受随机分组,2927名(97.0%)患者纳入修订意向治疗分析(早期策略组1465名患者,标准策略组1462名患者)。在这些患者中,早期策略组1418名 (96.8%) 患者与标准策略组 903名 (61.8%) 患者接受肾脏替代治疗。至90天时,早期策略组中643名 (43.9%) 患者及标准策略组中639名 (43.7%) 患者死亡(相对危险度,1.00;95% 可信区间 [CI],0.93 to 1.09;P=0.92)。在90天存活患者中,早期策略组814名患者中的85名 (10.4%) 以及标准策略组814名患者中的49名 (6.0%) 持续依赖肾脏替代治疗(相对危险度,1.74;95% CI,1.24 to 2.43)。早期策略组1503名患者中346名 (23.0%) 患者及标准策略中1489名患者中的245名 (16.5%) 患者发生不良事件 (P<0.001)。

CONCLUSIONS 结论

Among critically ill patients with acute kidney injury, an accelerated renal-replacement strategy was not associated with a lower risk of death at 90 days than a standard strategy.

对于罹患急性肾损伤的危重病患者,与标准策略相比,早期肾脏替代治疗策略并不伴随90天死亡风险降低。

(Funded by the Canadian Institutes of Health Research and others; STARRT-AKI ClinicalTrials.gov number, NCT02568722.)

[点评]

有关急性肾损伤肾脏替代治疗时机的研究,除了ELAIN研究外,其他RCT(包括AKIKI和IDEAL-ICU)都是阴性结果。鉴于近年来重症医学其他RCT的阴性结果,STARRT-AKI研究结果阴性其实并不意外。

问题在于,为什么我们崇尚的积极治疗反而是无效的?

  • 除了所谓肾脏替代治疗的绝对适应症外,其他的治疗指征可能并不正确,或者说未经验证;
  • 我们尚无法准确判断哪些患者肾脏功能在短时间内无法恢复,因而一定需要肾脏替代治疗(本研究标准策略组将近40%的患者未接受肾脏替代治疗);
  • 对于那些肾脏功能可以短期内恢复的患者,肾脏替代治疗增加了治疗的复杂程度,甚至增加不良事件的风险(本研究早期策略组不良事件发生率增加);
  • 尚不知道早期策略组肾脏替代治疗依赖比例为何升高?

恐怕需要重新审视早期治疗的理念,有的时候等待未必不是治疗

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