Evidence map›Paper›PMID 27093939›Full record

Trial reportTrials2016

Stress ulcer prophylaxis with a proton pump inhibitor versus placebo in critically ill patients (SUP-ICU trial): study protocol for a randomised controlled trial.

Mette Krag, Anders Perner, Jørn Wetterslev, Matt P Wise, Mark Borthwick, Stepani Bendel, Paolo Pelosi, Frederik Keus, Anne Berit Guttormsen, Joerg C Schefold and 2 more

Registry-linked trialOpen access · goldAbstract readPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02467621 (Stress Ulcer Prophylaxis in the Intensive Care Unit), which is not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
9.1field-weighted citation impact, top 2% 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.

NCT02467621 phase4completednot on this map

Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU)

TypeinterventionalSponsorDr. Morten Hylander MøllerRan2016 to 2018Enrolled3,350ConditionsGastrointestinal Bleeding, Stress UlcersArmsPantoprazole, Saline (0.9%)
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Article
  7. Audit on Practices of Stress Ulcer Prophylaxis in Intensive Care Unit Patients.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2020
    Article
  8. Article
  9. Is research from databases reliable? No.Intensive care medicine · 2019
    Article
  10. Review
  11. Article
  12. Complications and Pharmacologic Interventions of Invasive Positive Pressure Ventilation During Critical Illness.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2018
    Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Observational
  18. 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

12 authors at 6 institutions in 7 countries.

Mette KragDepartment of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. mette.krag.01@regionh.dk.
Anders PernerDepartment of Intensive Care 4131 and Centre for Research in Intensive Care (CRIC), Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Jørn WetterslevCopenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Matt P WiseDepartment of Adult Critical Care, University Hospital of Wales, Cardiff, UK.
Mark BorthwickPharmacy Department, Oxford University Hospitals NHS Trust, Oxford, UK.
Stepani BendelDepartment of Intensive Care Medicine, Kuopio University Hospital, Kuopio, Finland.
Paolo PelosiDepartment of Surgical Sciences and Integrated Diagnostics, IRCCS AOU San Martino IST, University of Genoa, Genoa, Italy.
Frederik KeusUniversity of Groningen, Department of Critical Care, University Medical Center Groningen, Groningen, The Netherlands.
Anne Berit GuttormsenDepartment of Anaesthesia and Intensive Care, Haukeland University Hospital and Clinical Institute 1 UiB, Bergen, Norway.
Joerg C SchefoldDepartment of Intensive Care Medicine, University Hospital Inselspital, Bern, Switzerland.
Morten Hylander MøllerDepartment of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
SUP-ICU investigators
Copenhagen University Hospital · DKKuopio University Hospital · FIUniversity Hospital of Wales · GBUniversity Medical Center Groningen · NLHaukeland University Hospital · NOUniversity Hospital of Bern · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCritically ill patients in the intensive care unit (ICU) are at risk of clinically important gastrointestinal bleeding, and acid suppressants are frequently used prophylactically. However, stress ulcer prophylaxis may increase the risk of serious adverse events and, additionally, the quantity and quality of evidence supporting the use of stress ulcer prophylaxis is low. The aim of the SUP-ICU trial is to assess the benefits and harms of stress ulcer prophylaxis with a proton pump inhibitor in adult patients in the ICU. We hypothesise that stress ulcer prophylaxis reduces the rate of gastrointestinal bleeding, but increases rates of nosocomial infections and myocardial ischaemia. The overall effect on mortality is unpredictable. METHODS/

designThe SUP-ICU trial is an investigator-initiated, pragmatic, international, multicentre, randomised, blinded, parallel-group trial of stress ulcer prophylaxis with a proton pump inhibitor versus placebo (saline) in 3350 acutely ill ICU patients at risk of gastrointestinal bleeding. The primary outcome measure is 90-day mortality. Secondary outcomes include the proportion of patients with clinically important gastrointestinal bleeding, pneumonia, Clostridium difficile infection or myocardial ischaemia, days alive without life support in the 90-day period, serious adverse reactions, 1-year mortality, and health economic analyses. The sample size will enable us to detect a 20 % relative risk difference (5 % absolute risk difference) in 90-day mortality assuming a 25 % event rate with a risk of type I error of 5 % and power of 90 %. The trial will be externally monitored according to Good Clinical Practice standards. Interim analyses will be performed after 1650 and 2500 patients.

conclusionThe SUP-ICU trial will provide high-quality data on the benefits and harms of stress ulcer prophylaxis with a proton pump inhibitor in critically ill adult patients admitted in the ICU.

trial registrationClinicalTrials.gov Identifier: NCT02467621 .

Indexed as

Anti-Ulcer AgentsClinical ProtocolsCost-Benefit AnalysisCritical IllnessCross InfectionDrug Administration ScheduleDrug CostsEnterocolitis, PseudomembranousEuropeHospital CostsHumansMyocardial IschemiaPeptic UlcerPeptic Ulcer HemorrhagePneumoniaProton Pump InhibitorsAnti-Ulcer AgentsProton Pump InhibitorsAdverse eventCritically illGastrointestinal bleedingIntensive care unitPlaceboRandomised clinical trialStress ulcer prophylaxis

Identifiers

PMID27093939
PMCPMC4837508
OpenAlexW2337712947

What OpenQuestion holds

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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.