NEJM：对危重成人患者应用平衡多电解质溶液与生理盐水的比较

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. 在平衡多电解质溶液（BMES）和0.9%氯化钠溶液（生理盐水）之间，对危重患者优先使用前者可否降低急性肾损伤或死亡风险，目前尚不确定。

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. 在一项双盲、随机、对照试验中，我们将重症监护病房（ICU）的危重患者随机分组，两组患者分别在补液疗法中接受BMES（Plasma-Lyte 148）或生理盐水90天。主要结局是随机分组后90日内的全因死亡。次要结局是接受新的肾脏替代治疗以及在ICU期间的肌酐水平最大增幅。

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. 本试验从澳大利亚和新西兰的53家ICU招募共计5037例患者，2515例被分配到BMES组，2522例被分配到生理盐水组。BMES组2433例患者中的530例（21.8%）和生理盐水组2413例患者中的530例（22.0%）在随机分组后90日内死亡，差异为-0.15个百分点（95%置信区间[CI]，-3.60~3.30；P=0.90）。BMES组2403例患者中的306例（12.7%）和生理盐水组2394例患者中的310例（12.9%）启动新的肾脏替代治疗，差异为-0.20个百分点（95% CI，-2.96~2.56）。在BMES组和生理盐水组中，血清肌酐水平的平均（±SD）最大增幅分别为0.41±1.06 mg/dL（36.6±94.0 μmol/L）和0.41±1.02 mg/dL（36.1±90.0 μmol/L），差异为0.01 mg/dL（95% CI，-0.05~0.06）（0.5 μmol/L [95% CI，-4.7~5.7]）。两组的不良事件和严重不良事件数量不存在有意义的差异。

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. opens in new tab.) 我们发现，在ICU的危重成人患者中，并无证据表明BMES组的死亡或急性肾损伤风险低于生理盐水组。（由澳大利亚国家健康和医学研究委员会[National Health and Medical Research Council of Australia]和新西兰健康研究理事会[Health Research Council of New Zealand]资助；PLUS在ClinicalTrials.gov注册号为NCT02721654。）

Simon Finfer, Sharon Micallef, Naomi Hammond, Balanced Multielectrolyte Solution versus Saline in Critically Ill Adults. DOI: 10.1056/NEJMoa2114464

翻译来自于：https://mp.weixin.qq.com/s/pOUd54Lt-jIUMOOrZ7UxTw