HCor Research Institute, São Paulo, Brazil.
Brazilian Research in Intensive Care Network, São Paulo, Brazil.
Am J Respir Crit Care Med. 2022 Jun 15;205(12):1419-1428. doi: 10.1164/rccm.202111-2484OC.
The effects of balanced crystalloid versus saline on clinical outcomes for ICU patients may be modified by the type of fluid that patients received for initial resuscitation and by the type of admission. To assess whether the results of a randomized controlled trial could be affected by fluid use before enrollment and admission type. Secondary analysis of the BaSICS (Balanced Solution in Intensive Care Study) trial, which compared a balanced solution (Plasma-Lyte 148) with 0.9% saline in the ICU. Patients were categorized according to fluid use in the 24 hours before enrollment in four groups (balanced solutions only, 0.9% saline only, a mix of both, and no fluid before enrollment) and according to admission type (planned, unplanned with sepsis, and unplanned without sepsis). The association between 90-day mortality and the randomization group was assessed using a hierarchical logistic Bayesian model. A total of 10,520 patients were included. There was a low probability that the balanced solution was associated with improved 90-day mortality in the whole trial population (odds ratio [OR], 0.95; 89% credible interval [CrI], 0.66-10.51; probability of benefit, 0.58); however, probability of benefit was high for patients who received only balanced solutions before enrollment (regardless of admission type, OR, 0.78; 89% CrI, 0.56-1.03; probability of benefit, 0.92), mostly because of a benefit in unplanned admissions due to sepsis (OR, 0.70; 89% CrI, 0.50-0.97; probability of benefit, 0.96) and planned admissions (OR, 0.79; 89% CrI, 0.65-0.97; probability of benefit, 0.97). There is a high probability that balanced solution use in the ICU reduces 90-day mortality in patients who exclusively received balanced fluids before trial enrollment. Clinical trial registered with www.clinicaltrials.gov (NCT02875873).
在 ICU 患者中,平衡晶体液与生理盐水对临床结局的影响可能会因患者最初复苏时使用的液体类型和入院类型而有所不同。为了评估一项随机对照试验的结果是否会受到入组前液体使用和入院类型的影响。对 BaSICS(平衡溶液在重症监护研究)试验的二次分析,该试验比较了 ICU 中平衡溶液(Plasma-Lyte 148)与 0.9%生理盐水的效果。根据入组前 24 小时内的液体使用情况,患者分为四组(仅使用平衡溶液、仅使用 0.9%生理盐水、两者混合使用、入组前无液体),并根据入院类型(计划入院、伴有脓毒症的非计划入院和无脓毒症的非计划入院)进行分类。使用分层逻辑贝叶斯模型评估 90 天死亡率与随机分组之间的关系。共纳入 10520 例患者。平衡溶液与整个试验人群的 90 天死亡率降低相关的可能性较低(比值比[OR],0.95;95%可信区间[CrI],0.66-10.51;获益概率,0.58);然而,仅在入组前接受平衡溶液的患者获益的可能性较高(无论入院类型如何,OR,0.78;95%CrI,0.56-1.03;获益概率,0.92),这主要是因为脓毒症引起的非计划入院(OR,0.70;95%CrI,0.50-0.97;获益概率,0.96)和计划入院(OR,0.79;95%CrI,0.65-0.97;获益概率,0.97)的获益。在 ICU 中使用平衡溶液极有可能降低仅在入组前接受平衡溶液的患者的 90 天死亡率。临床试验在 www.clinicaltrials.gov(NCT02875873)注册。