Balanced Crystalloids versus Saline in Critically Ill Adults

Matthew W. Semler, Wesley H. Self, Jonathan P. Wanderer, et al

N Engl J Med February 27, 2018

DOI: 10.1056/NEJMoa1711584

Abstract

BACKGROUND 背景

Both balanced crystalloids and saline are used for intravenous fluid administration in critically ill adults, but it is not known which results in better clinical outcomes.

平衡盐溶液及生理盐水均可用于成年危重病患者的静脉输液治疗，但对临床结局的影响尚不清楚。

METHODS 方法

In a pragmatic, cluster-randomized, multiple-crossover trial conducted in five intensive care units at an academic center, we assigned 15,802 adults to receive saline (0.9% sodium chloride) or balanced crystalloids (lactated Ringer’s solution or Plasma-Lyte A) according to the randomization of the unit to which they were admitted. The primary outcome was a major adverse kidney event within 30 days — a composite of death from any cause, new renal-replacement therapy, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline) — all censored at hospital discharge or 30 days, whichever occurred first.

这项实效性、群组随机、多重交叉临床试验在一个医学中心的5个ICU中进行。根据收治ICU的随机分组情况，15802名成年患者分别接受生理盐水（0.9% 氯化钠）或平衡盐溶液（乳酸林格氏液或Plasma-Lyte）输注。主要预后终点为30天内重要不良肾脏事件—这是一个复合终点，包括任何原因导致死亡，新发肾脏替代治疗或持续肾脏功能障碍（定义为肌酐水平叫基线值升高≥200%）—所有指标均在出院或30天截尾。

RESULTS 结果

Among the 7942 patients in the balanced-crystalloids group, 1139 (14.3%) had a major adverse kidney event, as compared with 1211 of 7860 patients (15.4%) in the saline group (marginal odds ratio, 0.91; 95% confidence interval [CI], 0.84 to 0.99; conditional odds ratio, 0.90; 95% CI, 0.82 to 0.99; P=0.04). In-hospital mortality at 30 days was 10.3% in the balanced-crystalloids group and 11.1% in the saline group (P=0.06). The incidence of new renal-replacement therapy was 2.5% and 2.9%, respectively (P=0.08), and the incidence of persistent renal dysfunction was 6.4% and 6.6%, respectively (P=0.60).

在平衡盐溶液组的7942名患者中，1139名(14.3%) 发生重要不良肾脏事件，生理盐水组7869名中 1211 名 (15.4%) 发生重要肾脏不良事件（边际比数比，0.91; 95% 可信限 [CI], 0.84 to 0.99; 条件比数比，0.90; 95% CI, 0.82 to 0.99; P=0.04）。

CONCLUSIONS 结论

Among critically ill adults, the use of balanced crystalloids for intravenous fluid administration resulted in a lower rate of the composite outcome of death from any cause, new renal-replacement therapy, or persistent renal dysfunction than the use of saline. (Funded by the Vanderbilt Institute for Clinical and Translational Research and others; SMART-MED and SMART-SURG ClinicalTrials.gov numbers, NCT02444988 and NCT02547779.)

在成年危重病患者，与生理盐水相比，使用平衡盐溶液进行静脉输液治疗能够减少包括任何原因导致死亡、新发肾脏替代治疗及持续肾脏功能障碍在内的复合预后指标发生率。