一项全院范围的开放标签整群交叉实用比较效果随机试验：比较生理盐水与乳酸林格氏液——FLUID试验的方案和统计分析计划

A Hospital-Wide Open-Label Cluster Crossover Pragmatic Comparative Effectiveness Randomized Trial Comparing Normal Saline to Ringer's Lactate: Protocol and Statistical Analysis Plan of The FLUID Trial.

作者信息

Shaw Julia F, Ouyang Yongdong, Fergusson Dean A, McArdle Tracy, Martin Claudio, Cook Deborah, Graham Ian D, Hawken Steven, McCartney Colin J L, Menon Kusum, Saginur Raphael, Seely Andrew, Stiell Ian, Fox-Robichaud Alison, English Shane, Marshall John, Thavorn Kednapa, Taljaard Monica, McIntyre Lauralyn A

机构信息

Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.

School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.

出版信息

JMIR Res Protoc. 2023 Oct 6;12:e51783. doi: 10.2196/51783.

DOI:10.2196/51783

PMID:37801356

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10589831/

Abstract

BACKGROUND

Normal saline (NS) and Ringer's lactate (RL) are the most common crystalloids given to hospitalized patients. Despite concern about possible harm associated with NS (eg, hyperchloremic metabolic acidosis, impaired kidney function, and death), few large multicenter randomized trials focused on critically ill patients have compared these fluids. Uncertainty exists about the effects of these fluids on clinically important outcomes across all hospitalized patients.

OBJECTIVE

The FLUID trial is a pragmatic, multicenter, 2×2 cluster crossover comparative effectiveness randomized trial that aims to evaluate the effectiveness of a hospital-wide policy that stocks either NS or RL as the main crystalloid fluid in 16 hospitals across Ontario, Canada.

METHODS

All hospitalized adult and pediatric patients (anticipated sample size 144,000 patients) with an incident admission to the hospital over the course of each study period will be included. Either NS or RL will be preferentially stocked throughout the hospital for 12 weeks before crossing to the alternate fluid for the subsequent 12 weeks. The primary outcome is a composite of death and hospital readmission within 90 days of hospitalization. Secondary outcomes include death, hospital readmission, dialysis, reoperation, postoperative reintubation, length of hospital stay, emergency department visits, and discharge to a facility other than home. All outcomes will be obtained from health administrative data, eliminating the need for individual case reports. The primary analysis will use cluster-level summaries to estimate cluster-average treatment effects.

RESULTS

The statistical analysis plan has been prepared "a priori" in advance of receipt of the trial data set from ICES and any analyses.

CONCLUSIONS

We describe the protocol and statistical analysis plan for the evaluation of primary and secondary outcomes for the FLUID trial.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04512950; https://classic.clinicaltrials.gov/ct2/show/NCT04512950.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51783.

摘要

背景

生理盐水（NS）和乳酸林格氏液（RL）是给予住院患者最常用的晶体液。尽管人们担心NS可能带来危害（如高氯性代谢性酸中毒、肾功能损害和死亡），但很少有针对重症患者的大型多中心随机试验比较过这些液体。对于这些液体对所有住院患者临床重要结局的影响仍存在不确定性。

目的

FLUID试验是一项务实的多中心2×2整群交叉比较效果随机试验，旨在评估一项全院范围政策的有效性，该政策在加拿大安大略省的16家医院将NS或RL作为主要晶体液储备。

方法

在每个研究期间因首次入院而住院的所有成年和儿科患者（预期样本量144,000例患者）将被纳入。在全院范围内，NS或RL将被优先储备12周，之后更换为另一种液体并持续12周。主要结局是住院90天内死亡和再次入院的复合结局。次要结局包括死亡、再次入院、透析、再次手术、术后再次插管、住院时间、急诊就诊以及出院至非家庭机构。所有结局将从卫生行政数据中获取，无需个体病例报告。主要分析将使用整群水平汇总来估计整群平均治疗效果。