A Phase 4 interventional study of Pantoprazole and Saline (0.9%) in Gastrointestinal Bleeding and Stress Ulcers, sponsored by Dr. Morten Hylander Møller. Completed at 33 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Dr. Morten Hylander Møller · Phase 4, Interventional, and Prevention
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.
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.
One or more of the following risk factors:
EXCLUSION CRITERIA:
Pantoprazole 40 mg
Drug: Pantoprazole
Saline (0.9%)
Other: Saline (0.9%)
40 mg x 1 daily intravenously from ICU admission to ICU discharge
Also known as: Pantoloc
10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
Mortality
Landmark mortality 90-days after randomization
Time frame: 90 days
Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia
Composite outcome of the number of participants with one or more of the mentioned conditions in the ICU
Time frame: Until ICU discharge, maximum 90 days
Number of Participants With Clinically Important GI Bleeding
Number of participants with one or more episodes of clinically important GI bleeding in the ICU
Time frame: Until ICU discharge, maximum 90 days
Number of Participants With One or More Infectious Adverse Events
Number of participants with one or more episodes of pneumonia or clostridium difficile infection in the ICU
Time frame: Until ICU discharge, maximum 90 days
Mortality
Data for landmark mortality 1 year after randomization.
Time frame: 1 year
Percentage of Days Alive Without Organ Support
Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
Time frame: Within 90 days
Number of Serious Adverse Reactions
Serious adverse reactions are: anaphylactic reactions, agranulocytosis, pancytopenia, acute hepatic failure, Steven Johnsons Syndrome and toxic epidermal necrolysis, interstitial nephritis and angioedema.
Time frame: Until ICU discharge, maximum 90 days
A Health Economic Analysis
This has not been completed yet.
Time frame: 90 days
| Milestone | Proton Pump Inhibitor (PPI) | Normal Saline |
|---|---|---|
| Started | 1645 | 1653 |
| Completed | 1644 | 1647 |
| Not completed | 1 | 6 |
Landmark mortality 90-days after randomization
| Participants | Proton Pump Inhibitor (PPI) | Normal Saline |
|---|---|---|
| Mortality | 510 | 499 |
Composite outcome of the number of participants with one or more of the mentioned conditions in the ICU
| Participants | Proton Pump Inhibitor (PPI) | Normal Saline |
|---|---|---|
| Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia | 360 | 372 |
Number of participants with one or more episodes of clinically important GI bleeding in the ICU
| Participants | Proton Pump Inhibitor (PPI) | Normal Saline |
|---|---|---|
| Number of Participants With Clinically Important GI Bleeding | 41 | 69 |
Number of participants with one or more episodes of pneumonia or clostridium difficile infection in the ICU
| Participants | Proton Pump Inhibitor (PPI) | Normal Saline |
|---|---|---|
| Number of Participants With One or More Infectious Adverse Events | 276 | 279 |
Data for landmark mortality 1 year after randomization.
| Participants | Proton Pump Inhibitor (PPI) | Normal Saline |
|---|---|---|
| Mortality | 610 | 601 |
Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
| percentage of days | Proton Pump Inhibitor (PPI) | Normal Saline |
|---|---|---|
| Percentage of Days Alive Without Organ Support | 92 | 92 |
Serious adverse reactions are: anaphylactic reactions, agranulocytosis, pancytopenia, acute hepatic failure, Steven Johnsons Syndrome and toxic epidermal necrolysis, interstitial nephritis and angioedema.
| Participants | Proton Pump Inhibitor (PPI) | Normal Saline |
|---|---|---|
| Number of Serious Adverse Reactions | 0 | 0 |
This has not been completed yet.
Results for this outcome have not been posted.
Collected over 90 days (for mortality 1 year). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Proton Pump Inhibitor (PPI) | 610/1,635 (37.3%) | 0/1,644 (0%) | 360/1,644 (21.9%) |
| Normal Saline | 601/1,626 (37%) | 0/1,647 (0%) | 372/1,647 (22.6%) |
| Event | Proton Pump Inhibitor (PPI) | Normal Saline |
|---|---|---|
| Clinically important eventsGeneral disorders | 360/1644 | 372/1647 |
| Age, Continuous(years) | Proton Pump Inhibitor (PPI) | Normal Saline | Total |
|---|---|---|---|
| Median | 67 (56 to 75) | 67 (55 to 75) | 67 (55 to 75) |
| Sex: Female, Male(Participants) | Proton Pump Inhibitor (PPI) | Normal Saline | Total |
|---|---|---|---|
| Female | 605 | 580 | 1185 |
| Male | 1039 | 1067 | 2106 |
| Race (NIH/OMB)(Participants) | Proton Pump Inhibitor (PPI) | Normal Saline | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1644 | 1647 | 3291 |
| Region of Enrollment(participants) | Proton Pump Inhibitor (PPI) | Normal Saline | Total |
|---|---|---|---|
| Netherlands | 88 | 84 | 172 |
| Norway | 96 | 101 | 197 |
| Finland | 128 | 130 | 258 |
| Denmark | 1061 | 1064 | 2125 |
| United Kingdom | 34 | 33 | 67 |
| Switzerland | 237 | 235 | 472 |
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Plan to share: Yes
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