平衡电解质溶液与生理盐水在危重症成人中的应用比较。

Balanced Multielectrolyte Solution versus Saline in Critically Ill Adults.

机构信息

From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.

出版信息

N Engl J Med. 2022 Mar 3;386(9):815-826. doi: 10.1056/NEJMoa2114464. Epub 2022 Jan 18.

DOI:10.1056/NEJMoa2114464

PMID:35041780

Abstract

BACKGROUND

Whether the use of balanced multielectrolyte solution (BMES) in preference to 0.9% sodium chloride solution (saline) in critically ill patients reduces the risk of acute kidney injury or death is uncertain.

METHODS

In a double-blind, randomized, controlled trial, we assigned critically ill patients to receive BMES (Plasma-Lyte 148) or saline as fluid therapy in the intensive care unit (ICU) for 90 days. The primary outcome was death from any cause within 90 days after randomization. Secondary outcomes were receipt of new renal-replacement therapy and the maximum increase in the creatinine level during ICU stay.

RESULTS

A total of 5037 patients were recruited from 53 ICUs in Australia and New Zealand - 2515 patients were assigned to the BMES group and 2522 to the saline group. Death within 90 days after randomization occurred in 530 of 2433 patients (21.8%) in the BMES group and in 530 of 2413 patients (22.0%) in the saline group, for a difference of -0.15 percentage points (95% confidence interval [CI], -3.60 to 3.30; P = 0.90). New renal-replacement therapy was initiated in 306 of 2403 patients (12.7%) in the BMES group and in 310 of 2394 patients (12.9%) in the saline group, for a difference of -0.20 percentage points (95% CI, -2.96 to 2.56). The mean (±SD) maximum increase in serum creatinine level was 0.41±1.06 mg per deciliter (36.6±94.0 μmol per liter) in the BMES group and 0.41±1.02 mg per deciliter (36.1±90.0 μmol per liter) in the saline group, for a difference of 0.01 mg per deciliter (95% CI, -0.05 to 0.06) (0.5 μmol per liter [95% CI, -4.7 to 5.7]). The number of adverse and serious adverse events did not differ meaningfully between the groups.

CONCLUSIONS

We found no evidence that the risk of death or acute kidney injury among critically ill adults in the ICU was lower with the use of BMES than with saline. (Funded by the National Health and Medical Research Council of Australia and the Health Research Council of New Zealand; PLUS ClinicalTrials.gov number, NCT02721654.).

摘要

背景

在危重症患者中，使用平衡电解质溶液（BMES）替代 0.9%氯化钠溶液（生理盐水）是否能降低急性肾损伤或死亡的风险尚不确定。

方法

在一项双盲、随机、对照试验中，我们将危重症患者随机分配至 ICU 中接受 BMES（Plasma-Lyte 148）或生理盐水作为液体治疗，为期 90 天。主要结局为随机分组后 90 天内的任何原因死亡。次要结局为接受新的肾脏替代治疗和 ICU 住院期间肌酐水平的最大升高。

结果

共有 5037 例患者来自澳大利亚和新西兰的 53 家 ICU-2515 例患者被分配至 BMES 组，2522 例患者被分配至生理盐水组。随机分组后 90 天内，BMES 组有 2433 例患者（21.8%）死亡，生理盐水组有 2413 例患者（22.0%）死亡，差异为-0.15 个百分点（95%置信区间[CI]，-3.60 至 3.30；P=0.90）。BMES 组有 2403 例患者（12.7%）接受了新的肾脏替代治疗，生理盐水组有 2394 例患者（12.9%）接受了新的肾脏替代治疗，差异为-0.20 个百分点（95%CI，-2.96 至 2.56）。BMES 组血清肌酐水平的最大升高均值（±SD）为 0.41±1.06 mg/dL（36.6±94.0 μmol/L），生理盐水组为 0.41±1.02 mg/dL（36.1±90.0 μmol/L），差异为 0.01 mg/dL（95%CI，-0.05 至 0.06）（0.5 μmol/L [95%CI，-4.7 至 5.7]）。两组的不良事件和严重不良事件数量无显著差异。