Department of Intensive Care, Copenhagen, Denmark; Collaboration for Research in Intensive Care, Copenhagen, Denmark.
Department of Intensive Care, Copenhagen, Denmark; Collaboration for Research in Intensive Care, Copenhagen, Denmark.
Chest. 2020 Jun;157(6):1478-1496. doi: 10.1016/j.chest.2019.11.050. Epub 2020 Jan 23.
IV fluids are recommended during the initial management of sepsis, but the quality of evidence is low, and clinical equipoise exists. We aimed to assess patient-important benefits and harms of lower vs higher fluid volumes in adult patients with sepsis.
We conducted a systematic review with meta-analysis and trial sequential analysis (TSA) of randomized clinical trials of IV fluid volume separation in adult patients with sepsis. We adhered to our published protocol; the Cochrane handbook; the Preferred Reporting Items for Systematic Reviews and Meta-Analyses; and the Grading of Recommendations Assessment, Development and Evaluation statements. The primary outcomes were all-cause mortality, serious adverse events (SAEs), and quality of life.
We included nine trials (n = 637); all were published after 2015 and had an overall high risk of bias. We found no statistically significant difference between lower vs higher fluid volumes in all-cause mortality (relative risk [RR], 0.87; 95% CI, 0.69-1.10; I = 0%; TSA-adjusted CI, 0.34-2.22) or SAEs (RR, 0.91; 95% CI, 0.78-1.05; I = 0%; TSA-adjusted CI, 0.68-1.21). No trials reported on quality of life. We did not find differences in the secondary or exploratory outcomes. The quality of evidence was very low across all outcomes.
In this systematic review, we found very low quantity and quality of evidence supporting the decision on the volumes of IV fluid therapy in adults with sepsis.
ClinicalTrials.gov; No.: NCT03668236; URL: www.clinicaltrials.gov.
在脓毒症的初始治疗中推荐使用静脉补液，但证据质量较低，且存在临床平衡。我们旨在评估脓毒症成人患者接受较低与较高补液量的患者重要结局的获益和危害。
我们对脓毒症成人患者静脉补液量分离的随机临床试验进行了系统评价、荟萃分析和试验序贯分析（TSA）。我们遵循已发表的方案、Cochrane 手册、系统评价和荟萃分析的首选报告项目以及推荐评估、制定和评估声明。主要结局是全因死亡率、严重不良事件（SAE）和生活质量。
我们纳入了 9 项试验（n=637）；所有试验均发表于 2015 年之后，且整体偏倚风险较高。我们发现，较低与较高补液量之间在全因死亡率（相对风险 [RR]，0.87；95%CI，0.69-1.10；I²=0%；TSA 调整 CI，0.34-2.22）或 SAE（RR，0.91；95%CI，0.78-1.05；I²=0%；TSA 调整 CI，0.68-1.21）方面均无统计学差异。没有试验报告生活质量。我们在次要或探索性结局方面也未发现差异。所有结局的证据质量均非常低。
在这项系统评价中，我们发现支持脓毒症成人患者静脉补液量决策的证据数量和质量均非常低。
ClinicalTrials.gov；编号：NCT03668236；网址：www.clinicaltrials.gov。
