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早期乳酸导向治疗 ICU 患者:一项多中心、开放标签、随机对照试验。

Early lactate-guided therapy in intensive care unit patients: a multicenter, open-label, randomized controlled trial.

机构信息

Department of Intensive Care, Erasmus MC University Medical Centre, Rotterdam, The Netherlands.

出版信息

Am J Respir Crit Care Med. 2010 Sep 15;182(6):752-61. doi: 10.1164/rccm.200912-1918OC. Epub 2010 May 12.

Abstract

RATIONALE

It is unknown whether lactate monitoring aimed to decrease levels during initial treatment in critically ill patients improves outcome.

OBJECTIVES

To assess the effect of lactate monitoring and resuscitation directed at decreasing lactate levels in intensive care unit (ICU) patients admitted with a lactate level of greater than or equal to 3.0 mEq/L.

METHODS

Patients were randomly allocated to two groups. In the lactate group, treatment was guided by lactate levels with the objective to decrease lactate by 20% or more per 2 hours for the initial 8 hours of ICU stay. In the control group, the treatment team had no knowledge of lactate levels (except for the admission value) during this period. The primary outcome measure was hospital mortality.

MEASUREMENTS AND MAIN RESULTS

The lactate group received more fluids and vasodilators. However, there were no significant differences in lactate levels between the groups. In the intention-to-treat population (348 patients), hospital mortality in the control group was 43.5% (77/177) compared with 33.9% (58/171) in the lactate group (P = 0.067). When adjusted for predefined risk factors, hospital mortality was lower in the lactate group (hazard ratio, 0.61; 95% confidence interval, 0.43-0.87; P = 0.006). In the lactate group, Sequential Organ Failure Assessment scores were lower between 9 and 72 hours, inotropes could be stopped earlier, and patients could be weaned from mechanical ventilation and discharged from the ICU earlier.

CONCLUSIONS

In patients with hyperlactatemia on ICU admission, lactate-guided therapy significantly reduced hospital mortality when adjusting for predefined risk factors. As this was consistent with important secondary endpoints, this study suggests that initial lactate monitoring has clinical benefit. Clinical trial registered with www.clinicaltrials.gov (NCT00270673).

摘要

背景

目前尚不清楚在危重病患者初始治疗期间,监测血乳酸并使其降低是否能够改善预后。

目的

评估在入住重症加强护理病房(ICU)时血乳酸水平≥3.0 mEq/L 的患者中,以降低血乳酸水平为目标的乳酸监测和复苏治疗对患者的影响。

方法

患者被随机分配到两组。在乳酸组中,治疗方案由血乳酸水平指导,目标是在 ICU 入住最初 8 小时内,每 2 小时使血乳酸降低 20%或更多。在对照组中,在此期间,治疗团队并不知道血乳酸水平(除了入院值)。主要观察指标为住院死亡率。

测量和主要结果

乳酸组接受了更多的液体和血管扩张剂。然而,两组之间的血乳酸水平没有显著差异。在意向治疗人群(348 例患者)中,对照组的住院死亡率为 43.5%(77/177),而乳酸组为 33.9%(58/171)(P=0.067)。在校正了预先设定的风险因素后,乳酸组的住院死亡率更低(风险比,0.61;95%置信区间,0.43-0.87;P=0.006)。在乳酸组中,9 至 72 小时时序性器官衰竭评估评分较低,正性肌力药可以更早停用,患者可以更早地从机械通气中撤机并离开 ICU。

结论

在入住 ICU 时存在高乳酸血症的患者中,在校正预先设定的风险因素后,乳酸指导的治疗显著降低了住院死亡率。由于这与重要的次要终点一致,因此本研究表明初始乳酸监测具有临床益处。这项研究已在 www.clinicaltrials.gov 上注册(NCT00270673)。

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