Evidence map›Paper›PMID 38057875›Full record

Trial reportTrials2023

REVISE: re-evaluating the inhibition of stress erosions in the ICU-statistical analysis plan for a randomized trial.

Diane Heels-Ansdell, Laurent Billot, Lehana Thabane, Waleed Alhazzani, Adam Deane, Gordon Guyatt, Simon Finfer, François Lauzier, John Myburgh, Paul Young and 16 more

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

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03374800 (Re-EValuating the Inhibition of Stress Erosions), 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
1.1field-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.

NCT03374800 phase3completednot on this map

Re-EValuating the Inhibition of Stress Erosions: Prophylaxis Against Gastrointestinal Bleeding in the Critically Ill (The REVISE) Trial

TypeinterventionalSponsorMcMaster UniversityRan2018 to 2024Enrolled4,800ConditionsGastrointestinal Hemorrhage (Clinically Important, Upper)ArmsPlacebo (0.9% saline), Pantoprazole
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Risk Factors for Patient-Important Upper Gastrointestinal Bleeding.American journal of respiratory and critical care medicine · 2025
    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

26 authors at 14 institutions in 5 countries.

Diane Heels-AnsdellDepartment of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Laurent BillotThe George Institute for Global Health, University of New South Wales, University of New South Wales Medicine & Health, Sydney, New South Wales, Australia.
Lehana ThabaneDepartment of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Waleed AlhazzaniDepartment of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Adam DeaneDepartment of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Australia.
Gordon GuyattDepartment of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Simon FinferCritical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
François LauzierDivision of Critical Care, Department of MedicineDepartment of Anesthesiology and Critical CareFaculty of Medicine, at l`Université LavalLaval UniversityUniversite Laval Faculte de medicine, Quebec, Canada.
John MyburghCritical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Paul YoungMedical Research Institute of New Zealand, Wellington, New Zealand.
Yaseen ArabiKing Saud bin Abdulaziz University for Health Sciences, Riyad, Saudi Arabia.
John MarshallDepartment of Surgery and Critical Care Medicine, Unity Health Toronto, University of Toronto, Toronto, Canada.
Shane EnglishDepartment of Medicine (Critical Care), Faculty of Medicine, University of Ottawa, Ottawa, Canada.
John MuscedereDepartment of Critical Care Medicine, Queens University| Kingston Health Sciences Centre, Kingston, Ontario, Canada.
Marlies OstermannDepartment of Critical Care, King's College London, London, UK.
Bala VenkateshThe George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
Nicole ZytarukDepartment of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Miranda HardieThe George Institute for Global Health, Newton, Australia.
Naomi HammondUniversity of New South Wales, Sydney, New South Wales, Australia.
Serena KnowlesThe George Institute for Global Health, Newton, Australia.
Lois SaundersAcademic Critical Care Office Room D176, Critical Care Medicine, St. Joseph's Healthcare Hamilton, 50 Charlton Avenue East, Hamilton, Ontario, Canada.
Alexis PooleThe University of Adelaide, Adelaide, Australia.
Abdulrahman Al-FaresInterdepartment Division of Critical Care Medicine, University of Toronto, Toronto, Canada.
Feng XieDepartment of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
Richard HallDalhousie University Faculty of Medicine, Halifax, Canada.
Deborah CookDepartment of Health Research Methods Evidence and Impact, McMaster University, Hamilton, Ontario, Canada. debcook@mcmaster.ca.ORCID http://orcid.org/0000-0002-4087-543X
Impact · CAUNSW Sydney · AUSt. Joseph’s Healthcare Hamilton · CAThe George Institute for Global Health · AUUniversity of Toronto · CADalhousie University · CAKing Saud bin Abdulaziz University for Health Sciences · SAKing's College London · GBMedical Research Institute of New Zealand · NZQueen's University · CAThe University of Adelaide · AUThe University of Melbourne · AUUniversité Laval · CAUniversity of Ottawa · CA

Funding

CIHR 201610PJT-378226-PJT-CEBA-18373CIHR 202207CL3-492565-CTP-CEBA-19215
6 · The paper itself

Abstract

backgroundThe REVISE (Re-Evaluating the Inhibition of Stress Erosions in the ICU) trial will evaluate the impact of the proton pump inhibitor pantoprazole compared to placebo in invasively ventilated critically ill patients.

objectiveTo outline the statistical analysis plan for the REVISE trial.

methodsREVISE is a randomized clinical trial ongoing in intensive care units (ICUs) internationally. Patients ≥ 18 years old, receiving invasive mechanical ventilation, and expected to remain ventilated beyond the calendar day after randomization are allocated to either 40 mg pantoprazole intravenously or placebo while mechanically ventilated.

resultsThe primary efficacy outcome is clinically important upper GI bleeding; the primary safety outcome is 90-day mortality. Secondary outcomes are ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine concentration, and duration of mechanical ventilation, ICU, and hospital length of stay. Following an interim analysis of results from 2400 patients (50% of 4800 target sample size), the data monitoring committee recommended continuing enrolment.

conclusionsThis statistical analysis plan outlines the statistical analyses of all outcomes, sensitivity analyses, and subgroup analyses. REVISE will inform clinical practice and guidelines worldwide.

trial registrationwww. CLINICALTRIALS: gov NCT03374800. November 21, 2017.

Indexed as

Intensive Care UnitsPneumonia, Ventilator-AssociatedAdolescentAdultCritical IllnessGastrointestinal HemorrhageHumansPantoprazoleProton Pump InhibitorsRespiration, ArtificialPantoprazoleProton Pump InhibitorsClostridioides difficile infectionCritically illGastrointestinal bleedingStress ulcerationVentilator-associated pneumonia

Identifiers

PMID38057875
PMCPMC10701941
OpenAlexW4389373660

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.