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 FORCID,Ouyang YongdongORCID,Fergusson Dean AORCID,McArdle TracyORCID,Martin ClaudioORCID,Cook DeborahORCID,Graham Ian DORCID,Hawken StevenORCID,McCartney Colin J LORCID,Menon KusumORCID,Saginur RaphaelORCID,Seely AndrewORCID,Stiell IanORCID,Fox-Robichaud AlisonORCID,English ShaneORCID,Marshall JohnORCID,Thavorn KednapaORCID,Taljaard MonicaORCID,McIntyre Lauralyn AORCID,

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

Publisher

JMIR Publications Inc.

Subject

General Medicine

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