Evidence map›Paper›PMID 36737087›Full record

Trial reportBMJ open2023

FLUID trial: a hospital-wide open-label cluster cross-over pragmatic comparative effectiveness randomised pilot trial comparing normal saline to Ringer's lactate.

Lauralyn Ann McIntyre, Dean A Fergusson, Tracy McArdle, Alison Fox-Robichaud, Shane W English, Claudio Martin, John Marshall, Deborah J Cook, Ian D Graham, Steven Hawken and 12 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02721485 (Crystalloid FLUID Choices for Resuscitation of Hospital Patients), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 23% 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.

NCT02721485 nacompletednot on this map

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

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2016 to 2018Enrolled30,000ConditionsFluid TherapyArmsRinger's Lactate, Normal Saline
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. 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

22 authors at 8 institutions in 1 country.

Lauralyn Ann McIntyreDepartment of Medicine (Critical Care), Ottawa Hospital Research Institute Clinical Epidemiology Program, Ottawa, Ontario, Canada lmcintyre@ottawahospital.on.ca.ORCID 0000-0001-7421-1407
Dean A FergussonClinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID 0000-0002-3389-2485
Tracy McArdleClinical Epidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Alison Fox-RobichaudMedicine, McMaster University, Hamilton, Ontario, Canada.ORCID 0000-0001-9912-3606
Shane W EnglishMedicine (Critical Care), University of Ottawa, Ottawa, Ontario, Canada.ORCID 0000-0002-9477-6146
Claudio MartinMedicine (Critical Care), London Health Sciences Centre, London, Ontario, Canada.
John MarshallSurgery/Critical Care Medicine, St. Michael's Hospital, Toronto, Ontario, Canada.
Deborah J CookDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Ian D GrahamClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Steven HawkenICES @uOttawa, Institute for Clinical Evaluative Sciences, Ottawa, Ontario, Canada.
Colin McCartneyAnesthesiology, University of Ottawa Faculty of Medicine, Ottawa, Ontario, Canada.
Kusum MenonDepartment of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
Raphael SaginurDepartment of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
Andrew SeelyEpidemiology, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Ian StiellDepartment of Emergency Medicine, Ottawa Hospital Research Institute Clinical Epidemiology Program, Ottawa, Ontario, Canada.
Kednapa ThavornClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID 0000-0003-4738-8447
Charles WeijerRotman Institute of Philospohy, Western University Faculty of Science, London, Ontario, Canada.
Akshai IyengarDepartment of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
John MuscedereCritical Care, Kingston General Hospital, Kingston, Ontario, Canada.
Alan J ForsterInternal Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
Monica TaljaardClinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID 0000-0002-3978-8961
Canadian Critical Care Trials Group
Ottawa Hospital · CAUniversity of Ottawa · CAMcMaster University · CAChildren's Hospital of Eastern Ontario · CAKingston General Hospital · CALondon Health Sciences Centre · CASt. Michael's Hospital · CAWestern University · CA

Funding

CIHR 2015-0619
6 · The paper itself

Abstract

objectivesNormal saline (NS) and Ringer's lactate (RL) are the most common crystalloids used for fluid therapy. Despite evidence of possible harm associated with NS (eg, hyperchloremic metabolic acidosis, impaired kidney function and death), few large multi-centre randomised trials have evaluated the effect of these fluids on clinically important outcomes. We conducted a pilot trial to explore the feasibility of a large trial powered for clinically important outcomes.

designFLUID was a pragmatic pilot cluster randomised cross-over trial.

settingFour hospitals in the province of Ontario, Canada

participantsAll hospitalised adult and paediatric patients with an incident admission to the hospital over the course of each study period.

interventionsA hospital wide policy/strategy which stocked either NS or RL throughout the hospital for 12 weeks before crossing over to the alternate fluid for the subsequent 12 weeks. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary feasibility outcome was study fluid protocol adherence. Secondary feasibility outcomes included time to Research Ethics Board (REB) approval and trial initiation. Primary (composite of death or re-admission to hospital in first 90 days of index hospitalisation) and secondary clinical outcomes were analysed descriptively.

resultsAmong 24 905 included patients, mean age 59.1 (SD 20.5); 13 977 (56.1%) were female and 21 150 (85.0%) had medical or surgical admitting diagnoses. Overall, 96 821 L were administered in the NS arm, and 78 348 L in the RL arm. Study fluid adherence to NS and RL was 93.7% (site range: 91.6%-98.0%) and 79.8% (site range: 72.5%-83.9%), respectively. Time to REB approval ranged from 2 to 48 days and readiness for trial initiation from 51 to 331 days. 5544 (22.3%) patients died or required hospital re-admission in the first 90 days.

conclusionsThe future large trial is feasible. Anticipating and addressing logistical challenges during the planning stages will be imperative. TRIAL REGISTRATION NUMBER: NCT02721485.

Indexed as

Fluid TherapySaline SolutionAdultChildFemaleHospitalsHumansMaleMiddle AgedOntarioPilot ProjectsRinger's LactateRinger's LactateSaline Solutionadult anaesthesiaadult intensive & critical careclinical trialsgeneral medicine (see internal medicine)surgery

Identifiers

PMID36737087
PMCPMC9900065
OpenAlexW4319078509

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.