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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days
Landmark mortality 90-days after randomization
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Morten Hylander Møller

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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