醋酸林格氏液与 0.9%生理盐水用于脓毒症患者的比较：一项多中心平行对照试验的研究方案。

Acetate Ringer's solution versus 0.9% saline for septic patients: study protocol for a multi-center parallel controlled trial.

机构信息

Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, 169 Donghu Road, Wuhan, 430071, Hubei, China.

Department of Critical Care Medicine, Wuhan Central Hospital, Huazhong University of Science & Technology, Tongji Medical School, Wuhan, 430030, Hubei, China.

出版信息

Trials. 2021 Jan 25;22(1):89. doi: 10.1186/s13063-020-05007-5.

DOI:10.1186/s13063-020-05007-5

PMID:33494795

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7830046/

Abstract

BACKGROUND

Previous study drew different conclusions on significant differences between saline and balanced crystalloid solution infused in critical illness but both showed a statistical difference in the sepsis subgroup. Thus, we will specifically focus on septic patients in this study to compare the effects of saline and balanced solution. We hypothesize that effects of saline on renal outcomes are related to the underline acute kidney injury (AKI) severity and total volumes of infusion.

METHODS/DESIGN: The investigators designed a pragmatic, multi-center parallel controlled trial recruiting 312 patients who are diagnosed with sepsis/septic shock in the intensive care unit (ICU) and will be assigned with either acetate Ringer's solution or saline in the corresponding month. Patients with an end-stage renal disease (ESRD) or who need renal replacement therapy (RRT) prior to or at the time of enrolment are excluded. Enrolled patients will be regarded as with mild, moderate, or severe sepsis on the basis of the severity of their illness and will be divided into subgroups according to their initial renal function and various intravenous infusion volumes when being analyzed. The primary outcome is major adverse kidney events within 28 days (MAKE28), including the composite of in-hospital death, receipt of new renal replacement therapy, or persistent renal dysfunction. Secondary outcomes include 28-day mortality, internal environment disturbance, incidence and duration of vasoactive drug treatment, duration of mechanical ventilation, duration of RRT, and ICU and hospital length of stay.

RESULTS AND CONCLUSIONS

To our knowledge, this study will be the first to focus on septic patients and provide credible and evident data on the comparison of outcome between acetate Ringer's solution and saline for intravenous infusion in adult septic patients on the basis of baseline renal function and infusion volumes taken into consideration.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03685214 . Registered on August 15, 2018.

摘要

背景

先前的研究对在危重病中输注生理盐水和平衡晶体溶液之间的显著差异得出了不同的结论，但两者在脓毒症亚组中均显示出统计学差异。因此，我们将在本研究中专门关注脓毒症患者，以比较生理盐水和平衡溶液的效果。我们假设生理盐水对肾脏结局的影响与潜在的急性肾损伤（AKI）严重程度和总输液量有关。

方法/设计：研究者设计了一项实用的、多中心平行对照试验，共招募了 312 名在重症监护病房（ICU）中被诊断为脓毒症/脓毒性休克的患者，并将在相应的月份中被分配到醋酸林格氏液或生理盐水组。患有终末期肾病（ESRD）或在入组前或入组时需要肾脏替代治疗（RRT）的患者被排除在外。根据疾病的严重程度，入组患者将被视为轻度、中度或重度脓毒症，并将根据其初始肾功能和分析时的各种静脉输液量分为亚组。主要结局是 28 天内的主要不良肾脏事件（MAKE28），包括住院期间死亡、接受新的肾脏替代治疗或持续肾功能障碍的复合事件。次要结局包括 28 天死亡率、内环境紊乱、血管活性药物治疗的发生率和持续时间、机械通气时间、RRT 时间、ICU 和住院时间。