Evidence map›Paper›PMID 37801356›Full record

ArticleJMIR research protocols2023

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.

Julia F Shaw, Yongdong Ouyang, Dean A Fergusson, Tracy McArdle, Claudio Martin, Deborah Cook, Ian D Graham, Steven Hawken, Colin J L McCartney, Kusum Menon and 10 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JMIR research protocols, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04512950 (Crystalloid FLUID Choices for Resuscitation of Hospital Patients), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 28% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04512950 phase4completednot on this map

Crystalloid FLUID Choices for Resuscitation of Hospital Patients: A Pragmatic Cluster Cross Over Trial

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2016 to 2020Enrolled43,626ConditionsFluid TherapyArmsRinger's lactate, 0.9% saline
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Randomized Trials Using Provincial Health Numbers for Group Assignment.Canadian journal of kidney health and disease · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 7 institutions in 1 country.

Julia F ShawClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0002-9768-1177
Yongdong OuyangClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0002-8692-2991
Dean A FergussonClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0002-3389-2485
Tracy McArdleClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0002-4836-7894
Claudio MartinDivision of Critical Care Medicine, London Health Sciences Centre, Western University, London, ON, Canada.ORCID https://orcid.org/0000-0003-3971-3166
Deborah CookDepartments of Medicine, Clinical Epidemiology and Biostatistics, St. Joseph's Healthcare Hamilton, McMaster University, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0002-4087-543X
Ian D GrahamClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0002-3669-1216
Steven HawkenClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0002-3341-9022
Colin J L McCartneyDepartment of Anesthesiology, The Ottawa Hospital, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0001-5312-0012
Kusum MenonChildren's Hospital of Eastern Ontario, University of Ottawa, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0003-0932-9243
Raphael SaginurDepartment of Medicine, Infectious Diseases, The Ottawa Hospital, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0002-5926-8920
Andrew SeelyClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0002-6459-8801
Ian StiellClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0002-2583-6408
Alison Fox-RobichaudDepartment of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.ORCID https://orcid.org/0000-0001-9912-3606
Shane EnglishClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0002-9477-6146
John MarshallDepartment of Surgery, St. Michael's Hospital, Toronto, ON, Canada.ORCID https://orcid.org/0000-0002-7902-6291
Kednapa ThavornClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0003-4738-8447
Monica TaljaardClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0002-3978-8961
Lauralyn A McIntyre *Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.ORCID https://orcid.org/0000-0001-7421-1407
Canadian Critical Care Trials Group
University of Ottawa · CAOttawa Hospital · CAMinnow Environmental (Canada) · CASt. Joseph’s Healthcare Hamilton · CASt. Michael's Hospital · CAThrombosis and Atherosclerosis Research Institute · CAWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNormal 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.

objectiveThe 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.

methodsAll 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.

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

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

trial registrationClinicalTrials.gov NCT04512950; https://classic.clinicaltrials.gov/ct2/show/NCT04512950. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51783.

Indexed as

cluster randomized trialcomparative effectivenessfluid therapynormal salinepragmaticRinger’s lactatestatistical analysis plan

Identifiers

PMID37801356
PMCPMC10589831
OpenAlexW4386142532

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.