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Stress Ulcer Prophylaxis in the Intensive Care Unit

NCT02467621 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3350

Last updated 2026-05-19

Study results available
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Summary

Stress ulcer prophylaxis (SUP) is standard of care in the intensive care unit (ICU), however the quantity and quality of evidence is low and potential harm has been reported.

The aim of the SUP-ICU trial is to asses the overall benefits and harms of SUP with proton pump inhibitor in adult critically ill patients in the ICU.

Conditions

  • Gastrointestinal Bleeding
  • Stress Ulcers

Interventions

DRUG

Pantoprazole

40 mg x 1 daily intravenously from ICU admission to ICU discharge

OTHER

Saline (0.9%)

10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • Dr. Morten Hylander Møller

    lead OTHER

Principal Investigators

  • Morten Hylander Møller, MD, PhD · Rigshospitalet, Denmark

  • Anders Perner, MD, PhD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-10-22
Completion
2018-01-21

Countries

  • Denmark
  • Finland
  • Netherlands
  • Norway
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02467621 on ClinicalTrials.gov