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.
338 studies on the registry are indexed under Gastrointestinal Hemorrhage; 77 are open to participants now.
This study's enrollment of 3,350 is above the median of 98 across 210 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →This is the only study on the registry with Dr. Morten Hylander Møller as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
One or more of the following risk factors:
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Ran from Jan 2016 to primary completion in Oct 2017, 21 months.
Results were first posted in Jun 2019, 1 year 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pantoprazole