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NCT Number: NCT02467621

Stress Ulcer Prophylaxis in the Intensive Care Unit

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pantoprazole

Drug

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

Other names: Pantoloc

Saline (0.9%)

Other

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

Primary outcomes

  1. Mortality

    Time frame: 90 days

    Landmark mortality 90-days after randomization

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Mortality

    Time frame: 1 year

    Data for landmark mortality 1 year after randomization.

  5. 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

  6. 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.

  7. A Health Economic Analysis

    Time frame: 90 days

    This has not been completed yet.

Sponsors and collaborators

Lead sponsor

Dr. Morten Hylander Møller

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SUP-ICU

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jun 10, 2015
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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