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

April 27, 2026 updated by: Dr. Morten Hylander Møller

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Critically ill patients in the ICU are at risk of stress related gastrointestinal (GI) bleeding, and SUP is recommended. However, the quantity and quality of evidence supporting SUP is low and has been questioned. Furthermore studies have shown that proton pump inhibitors (PPIs) may increase the risk of pneumonia, clostridium difficile infection and acute myocardial ischemia. The aim of the SUP-ICU trial is to assess the benefits and harms of SUP with PPI in adult critically ill patients in the ICU.

Study Type

Interventional

Enrollment (Actual)

3350

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Dept. of Intensive Care, Aalborg University Hospital
      • Aarhus, Denmark, 8000
        • Dept. of Intensive Care, Århus University Hospital Nørrebrogade
      • Aarhus, Denmark, 8000
        • Dept. of Intensive Care, Århus University Hospital Skejby
      • Copenhagen, Denmark, 2100
        • Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet
      • Copenhagen, Denmark, 2400
        • Dept. of Intensive Care, Bispebjerg Hospital
      • Copenhagen, Denmark, 2100
        • Dept. of Neurointensive Care, Copenhagen University Hospital Rigshospitalet
      • Herlev, Denmark, 2730
        • Dept. of Intensive Care, Copenhagen University Hospital Herlev
      • Herning, Denmark, 7400
        • Dept. of Intensive Care, Herning Hospital
      • Hillerød, Denmark, 3400
        • Dept. of Intensive Care, Hillerød Hospital
      • Hjørring, Denmark, 9800
        • Dept. of Intensive Care, Hjørring Hospital
      • Holbæk, Denmark, 4300
        • Dept. of Intensive Care, Holbæk Hospital
      • Holstebro, Denmark, 7500
        • Dept. of Intensive Care, Holstebro Hospital
      • Køge, Denmark, 4600
        • Dept. of Intensive Care, Køge University Hospital
      • Nykøbing Falster, Denmark, 4800
        • Dept. of Intensive Care, Nykøbing Falster Sygehus
      • Randers, Denmark, 8930
        • Dept. of Intensive Care, Randers Hospital
      • Roskilde, Denmark, 4000
        • Dept. of Intensive Care, Roskilde Hospital
      • Slagelse, Denmark, 4200
        • Dept. of Intensive Care, Slagelse Hospital
      • Vejle, Denmark, 7100
        • Dept. of Intensive Care, Vejle Hospital
      • Viborg, Denmark, 8800
        • Dept. of Intensive Care, Viborg Hospital
  • Finland
      • Helsinki, Finland, 00120
        • Dept. of Intensive Care, Helsinki University Hospital
      • Kuopio, Finland, 70029
        • Dept. of Intensive Care, Kuopio University Hospital
      • Oulu, Finland, 90210
        • Dept. of Intensive Care, Oulu University Hospital
      • Tampere, Finland, 33520
        • Dept. of Intensive Care, Tampere University Hospital
      • Turku, Finland, 20521
        • Dept. of Intensive Care, Turku University Hospital
  • Netherlands
      • Groningen, Netherlands, 9713
        • Dept. of Intensive Care, University Medical Center Groningen
      • Heerlen, Netherlands, 6419
        • Dept. of Intensive Care, Heerlen Hospital
  • Norway
      • Bergen, Norway, 5021
        • Dept. of Intensive Care, Bergen University Hospital
      • Lørenskog, Norway, 1478
        • Dept. of Intensive Care, Akershus University Hospital
      • Oslo, Norway, 0450
        • Dept. of Intensive Care, Oslo University Hospital
      • Stavanger, Norway, 4011
        • Dept. of Intensive Care, Stavanger University Hospital
  • Switzerland
      • Basel, Switzerland, 4056
        • Dept. of Intensive Care, Basel University Hospital
      • Bern, Switzerland, 3010
        • Dept. of Intensive Care, Bern University Hospital
  • United Kingdom
      • Cardiff, United Kingdom
        • Dept. of Intensive Care, University Hospital of Wales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA:

  • Acute admission to the ICU
  • Age ≥ 18 years

  • One or more of the following risk factors:

    • Shock (continuous infusion with vasopressors or inotropes, systolic blood pressure < 90 mmHg, mean arterial blood pressure < 70 mmHg or lactate > 4 mmol/l)
    • Acute or chronic intermittent or continuous renal replacement therapy
    • Invasive mechanical ventilation which is expected to last > 24 hours
    • Coagulopathy (platelets < 50 x 109/l or international normalized ratio (INR) > 1.5 or prothrombin time (PT) > 20 seconds) documented within the last 24 hours
    • Ongoing treatment with anticoagulant drugs (prophylaxis doses excluded)
    • History of coagulopathy (platelets < 50 x 109/l or INR > 1.5 or PT > 20 seconds) within 6 months prior to hospital admission
    • History of chronic liver disease (portal hypertension, cirrhosis proven by biopsy, computed tomography (CT) scan or ultrasound, history of variceal bleeding or hepatic encephalopathy in the past medical history)

EXCLUSION CRITERIA:

  • Contraindications to PPI
  • Ongoing treatment with PPI and/or H2RA on a daily basis
  • GI bleeding of any origin during current hospital admission
  • Diagnosed with peptic ulcer during current hospital admission
  • Organ transplant during current hospital admission
  • Withdrawal from active therapy or brain death
  • Fertile woman with positive urine human chorionic gonadotropin (hCG) or plasma-hCG
  • Consent according to national regulations not obtainable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proton pump inhibitor (PPI)
Pantoprazole 40 mg
Drug: Pantoprazole
40 mg x 1 daily intravenously from ICU admission to ICU discharge
Other Names:
  • Pantoloc
Placebo Comparator: Normal saline
Saline (0.9%)
Other: Saline (0.9%)
10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days
Landmark mortality 90-days after randomization
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia
Time Frame: Until ICU discharge, maximum 90 days
Composite outcome of the number of participants with one or more of the mentioned conditions in the ICU
Until ICU discharge, maximum 90 days
Number of Participants With Clinically Important GI Bleeding
Time Frame: Until ICU discharge, maximum 90 days
Number of participants with one or more episodes of clinically important GI bleeding in the ICU
Until ICU discharge, maximum 90 days
Number of Participants With One or More Infectious Adverse Events
Time Frame: Until ICU discharge, maximum 90 days
Number of participants with one or more episodes of pneumonia or clostridium difficile infection in the ICU
Until ICU discharge, maximum 90 days
Mortality
Time Frame: 1 year
Data for landmark mortality 1 year after randomization.
1 year
Percentage of Days Alive Without Organ Support
Time Frame: Within 90 days
Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
Within 90 days
Number of Serious Adverse Reactions
Time Frame: Until ICU discharge, maximum 90 days
Serious adverse reactions are: anaphylactic reactions, agranulocytosis, pancytopenia, acute hepatic failure, Steven Johnsons Syndrome and toxic epidermal necrolysis, interstitial nephritis and angioedema.
Until ICU discharge, maximum 90 days
A Health Economic Analysis
Time Frame: 90 days
This has not been completed yet.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Morten Hylander Møller

Collaborators

Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research

Investigators

  • Study Chair: Anders Perner, MD, PhD, Rigshospitalet, Denmark
  • Principal Investigator: Morten Hylander Møller, MD, PhD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

October 22, 2017

Study Completion (Actual)

January 21, 2018

Study Registration Dates

First Submitted

June 5, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimated)

June 10, 2015

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RH-ITA-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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