Evidence map›Paper›PMID 28459708›Full record

Trial reportCritical care medicine2017

Withholding Pantoprazole for Stress Ulcer Prophylaxis in Critically Ill Patients: A Pilot Randomized Clinical Trial and Meta-Analysis.

Waleed Alhazzani, Gordon Guyatt, Mohammed Alshahrani, Adam M Deane, John C Marshall, Richard Hall, John Muscedere, Shane W English, François Lauzier, Lehana Thabane and 10 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Critical care medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 52 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 12 pooled it
10.9field-weighted citation impact, top 1% 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.

NCT03372707 nacompletednot on this mapstarted 2018, after this paper: background citation

Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients Pilot Trial

TypeinterventionalSponsorMcMaster UniversityRan2018 to 2019Enrolled100ConditionsLaryngeal EdemaArmsCuff Leak Test
NCT05456542 phase3completednot on this mapstarted 2023, after this paper: background citation

Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COSMIC): A Pilot Randomized Controlled Trial

TypeinterventionalSponsorSt. Joseph's Healthcare HamiltonRan2023 to 2025Enrolled100ConditionsRespiratory FailureArmsCuff Leak Test, Dexamethasone 4mg
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 12 syntheses or guidelines pooled it, 107 citations in OpenAlex.

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  5. [S3 Guideline Sepsis-prevention, diagnosis, therapy, and aftercare : Long version].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2020
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 8 institutions in 4 countries.

Waleed Alhazzani1Department of Medicine, McMaster University, Hamilton, ON, Canada.2Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada.3Department of Critical Care, University of Dammam, Dammam, Saudi Arabia.4Discipline of Acute Care Medicine, University of Adelaide, Adelaide, SA, Australia.5Department of Surgery and Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.6Departments of Anesthesia, Pain Management and Perioperative Medicine and Critical Care Medicine, Dalhousie University, Halifax, NS, Canada.7Department of Critical Care, Queens University, Kingston, ON, Canada.8Department of Medicine (Critical Care), University of Ottawa, Ottawa, ON, Canada.9Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.10Departments of Medicine, Anesthesiology and Critical Care, Université Laval, Quebec City, QC, Canada.11Biostatistics Unit, St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.12Intensive Care Department, King Saud Bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.13The George Institute for Global Health and Royal North Shore Hospital, University of Sydney, Sydney, NSW, Australia.14Department of Medicine, University of Toronto, Toronto, ON, Canada.15Department of Internal Medicine, College of Medicine and Health Sciences, UAE University, Al Ain, United Arab Emirates.
Gordon Guyatt
Mohammed Alshahrani
Adam M Deane
John C Marshall
Richard Hall
John Muscedere
Shane W English
François Lauzier
Lehana Thabane
Yaseen M Arabi
Tim Karachi
Bram Rochwerg
Simon Finfer
Nick Daneman
Fayez Alshamsi
Nicole Zytaruk
Diane Heel-Ansdell
Deborah Cook
Canadian Critical Care Trials Group
McMaster University · CAImam Abdulrahman Bin Faisal University · SAKing Abdullah International Medical Research Center · SAUnited Arab Emirates University · AEUniversity of Adelaide · AUUniversity of Ottawa · CAUniversity of Sydney · AUUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionA decreased frequency of upper gastrointestinal bleeding and a possible association of proton pump inhibitor use with Clostridium difficile and ventilator-associated pneumonia have raised concerns recently. The Reevaluating the Inhibition of Stress Erosions Pilot Trial determined the feasibility of undertaking a larger trial investigating the efficacy and safety of withholding proton pump inhibitors in critically ill patients.

methodsIn 10 ICUs, we randomized adult ICU patients anticipated to be mechanically ventilated for greater than or equal to 48 hours to receive 40 mg of IV pantoprazole daily or placebo. We excluded patients who had acute or recent gastrointestinal bleed, used dual antiplatelet agents, had a medical condition requiring proton pump inhibitor treatment, or had already received more than one dose of acid suppression daily. Patients, families, clinicians, and research staff were blinded. We conducted a systematic review and meta-analysis of similar trials. MAIN

resultsNinety-one patients (49 pantoprazole and 42 placebo) from 10 centers in Canada, Saudi Arabia, and Australia were enrolled. All feasibility goals were met: 1) recruitment rate was 2.6 patients per month; 2) consent rate was 77.8%; and 3) protocol adherence was 97.7%. Upper gastrointestinal bleeding developed in 6.1% of patients in the pantoprazole group and 4.8% in the placebo group (p = 1.0). Ventilator-associated pneumonia developed in 20.4% of patients in the pantoprazole group and 14.3% in the placebo group (p = 0.58). C. difficile was identified in 4.1% pantoprazole patients and in 2.4% placebo patients (p = 1.0). We meta-analyzed five trials (604 patients) of proton pump inhibitors versus placebo; there was no statistically significant difference in the risk of upper gastrointestinal bleeding, infections, or mortality.

conclusionsOur results support the feasibility of a larger trial to evaluate the safety of withholding stress ulcer prophylaxis. Although the results are imprecise, there was no alarming increase in the risk of upper gastrointestinal bleeding; the effect of proton pump inhibitors on ventilator-associated pneumonia and C. difficile remain unclear.

Indexed as

Critical Illness2-PyridinylmethylsulfinylbenzimidazolesAdultAgedClostridium InfectionsDouble-Blind MethodGastrointestinal HemorrhageHumansIntensive Care UnitsMiddle AgedPantoprazolePilot ProjectsPneumonia, Ventilator-AssociatedProton Pump InhibitorsStomach Ulcer2-PyridinylmethylsulfinylbenzimidazolesPantoprazoleProton Pump Inhibitors

Identifiers

PMID28459708
OpenAlexW2609793605

What OpenQuestion holds

Textmetadata
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.