Full text

Turn on search term navigation

© 2023. This work is licensed under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

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

Details

Title
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
Author
Shaw, Julia F  VIAFID ORCID Logo  ; Ouyang, Yongdong  VIAFID ORCID Logo  ; Fergusson, Dean A  VIAFID ORCID Logo  ; McArdle, Tracy  VIAFID ORCID Logo  ; Martin, Claudio  VIAFID ORCID Logo  ; Cook, Deborah  VIAFID ORCID Logo  ; Graham, Ian D  VIAFID ORCID Logo  ; Hawken, Steven  VIAFID ORCID Logo  ; McCartney, Colin J L  VIAFID ORCID Logo  ; Menon, Kusum  VIAFID ORCID Logo  ; Saginur, Raphael  VIAFID ORCID Logo  ; Seely, Andrew  VIAFID ORCID Logo  ; Stiell, Ian  VIAFID ORCID Logo  ; Fox-Robichaud, Alison  VIAFID ORCID Logo  ; English, Shane  VIAFID ORCID Logo  ; Marshall, John  VIAFID ORCID Logo  ; Thavorn, Kednapa  VIAFID ORCID Logo  ; Taljaard, Monica  VIAFID ORCID Logo  ; McIntyre, Lauralyn A  VIAFID ORCID Logo  ; Canadian Critical Care Trials Group 14
First page
e51783
Publication year
2023
Publication date
2023
Publisher
JMIR Publications
e-ISSN
19290748
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2918522677
Copyright
© 2023. This work is licensed under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.