Gastrointestinal BleedingPhase 4SUP-ICUNCT02467621
Stress Ulcer Prophylaxis in the Intensive Care Unit
A Phase 4 study testing Pantoprazole and Saline (0.9%) in people with Gastrointestinal Bleeding and Stress Ulcers, run by Dr. Morten Hylander Møller at 33 sites in 6 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Bleeding, Stress Ulcers
- What is being tested?
- Pantoprazole and Saline (0.9%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,350 participants
- Where
- 33 sitesin 6 countries
- Study dates
- Jan 2016to 21 Jan 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
Denmark19 sites
Dept. of Intensive Care, Aalborg University Hospital
Aalborg, 9000
Dept. of Intensive Care, Århus University Hospital Nørrebrogade
Aarhus, 8000
Dept. of Intensive Care, Århus University Hospital Skejby
Aarhus, 8000
Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100
Dept. of Neurointensive Care, Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100
Dept. of Intensive Care, Bispebjerg Hospital
Copenhagen, 2400
Dept. of Intensive Care, Copenhagen University Hospital Herlev
Herlev, 2730
Dept. of Intensive Care, Herning Hospital
Herning, 7400
Dept. of Intensive Care, Hillerød Hospital
Hillerød, 3400
Dept. of Intensive Care, Hjørring Hospital
Hjørring, 9800
Dept. of Intensive Care, Holbæk Hospital
Holbæk, 4300
Dept. of Intensive Care, Holstebro Hospital
Holstebro, 7500
Dept. of Intensive Care, Køge University Hospital
Køge, 4600
Dept. of Intensive Care, Nykøbing Falster Sygehus
Nykøbing Falster, 4800
Dept. of Intensive Care, Randers Hospital
Randers, 8930
Dept. of Intensive Care, Roskilde Hospital
Roskilde, 4000
Dept. of Intensive Care, Slagelse Hospital
Slagelse, 4200
Dept. of Intensive Care, Vejle Hospital
Vejle, 7100
Dept. of Intensive Care, Viborg Hospital
Viborg, 8800
Finland5 sites
Dept. of Intensive Care, Helsinki University Hospital
Helsinki, 00120
Dept. of Intensive Care, Kuopio University Hospital
Kuopio, 70029
Dept. of Intensive Care, Oulu University Hospital
Oulu, 90210
Dept. of Intensive Care, Tampere University Hospital
Tampere, 33520
Dept. of Intensive Care, Turku University Hospital
Turku, 20521
Norway4 sites
Dept. of Intensive Care, Bergen University Hospital
Bergen, 5021
Dept. of Intensive Care, Akershus University Hospital
Lørenskog, 1478
Dept. of Intensive Care, Oslo University Hospital
Oslo, 0450
Dept. of Intensive Care, Stavanger University Hospital
Stavanger, 4011
Netherlands2 sites
Dept. of Intensive Care, University Medical Center Groningen
Groningen, 9713
Dept. of Intensive Care, Heerlen Hospital
Heerlen, 6419
Switzerland2 sites
Dept. of Intensive Care, Basel University Hospital
Basel, 4056
Dept. of Intensive Care, Bern University Hospital
Bern, 3010
United Kingdom1 site
Dept. of Intensive Care, University Hospital of Wales
Cardiff
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastrointestinal Bleeding, Stress Ulcers
- Being tested
- Pantoprazole, Saline (0.9%)
- Keywords
- Stress ulcer prophylaxis, Proton pump inhibitor, Pneumonia, Clostridium difficile infection
- Medical subject headings
- Gastrointestinal Hemorrhage, Duodenal Ulcer, Pneumonia, Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
Also called Pantoloc
40 mg x 1 daily intravenously from ICU admission to ICU discharge
Saline (0.9%)Other
10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
| Study group | Role | What they receive |
|---|---|---|
| Proton pump inhibitor (PPI) | Experimental | Pantoprazole 40 mg Receives: Drug: Pantoprazole |
| Normal saline | Placebo comparator | Saline (0.9%) Receives: Other: Saline (0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Landmark mortality 90-days after randomization
Measured: 90 days
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: Until ICU discharge, maximum 90 days
Mortality
Data for landmark mortality 1 year after randomization.
Measured: 1 year
Percentage of Days Alive Without Organ Support
Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
Measured: 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.
Measured: Until ICU discharge, maximum 90 days
A Health Economic Analysis
This has not been completed yet.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJan 2016
- Primary completion22 Oct 2017
- Study completion21 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Morten Hylander Møller
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Sponsor-investigator, Dr. Morten Hylander Møller, Scandinavian Critical Care Trials Group
- Investigators
- Morten Hylander Møller, MD, PhD, Principal investigator, Copenhagen University Hospital, RigshospitaletAnders Perner, MD, PhD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467621
- Sponsor's protocol ID
- RH-ITA-006
- Acronym
- SUP-ICU
- Status last verified
- Oct 2022
- First submitted
- 5 Jun 2015
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Krag M, Perner A, Wetterslev J, Wise MP, Hylander Moller M. Stress ulcer prophylaxis versus placebo or no prophylaxis in critically ill patients. A systematic review of randomised clinical trials with meta-analysis and trial sequential analysis. Intensive Care Med. 2014 Jan;40(1):11-22. doi: 10.1007/s00134-013-3125-3. Epub 2013 Oct 19.
PubMed 24141808Krag M, Perner A, Wetterslev J, Wise MP, Borthwick M, Bendel S, McArthur C, Cook D, Nielsen N, Pelosi P, Keus F, Guttormsen AB, Moller AD, Moller MH; SUP-ICU co-authors. Prevalence and outcome of gastrointestinal bleeding and use of acid suppressants in acutely ill adult intensive care patients. Intensive Care Med. 2015 May;41(5):833-45. doi: 10.1007/s00134-015-3725-1. Epub 2015 Apr 10.
PubMed 25860444Halling CMB, Moller MH, Marker S, Krag M, Kjellberg J, Perner A, Gyrd-Hansen D. The effects of pantoprazole vs. placebo on 1-year outcomes, resource use and employment status in ICU patients at risk for gastrointestinal bleeding: a secondary analysis of the SUP-ICU trial. Intensive Care Med. 2022 Apr;48(4):426-434. doi: 10.1007/s00134-022-06631-2. Epub 2022 Feb 5.
PubMed 35122105Granholm A, Marker S, Krag M, Zampieri FG, Thorsen-Meyer HC, Kaas-Hansen BS, van der Horst ICC, Lange T, Wetterslev J, Perner A, Moller MH. Heterogeneity of treatment effect of prophylactic pantoprazole in adult ICU patients: a post hoc analysis of the SUP-ICU trial. Intensive Care Med. 2020 Apr;46(4):717-726. doi: 10.1007/s00134-019-05903-8. Epub 2020 Jan 14.
PubMed 31938829Granholm A, Lange T, Anthon CT, Marker S, Krag M, Meyhoff TS, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Schefold JC, Wetterslev J, Perner A, Moller MH. Time to onset of gastrointestinal bleeding in the SUP-ICU trial: A pre-planned substudy. Acta Anaesthesiol Scand. 2019 Nov;63(10):1346-1356. doi: 10.1111/aas.13459. Epub 2019 Sep 11.
PubMed 31441031Granholm A, Marker S, Krag M, Zampieri FG, Thorsen-Meyer HC, Kaas-Hansen BS, van der Horst ICC, Lange T, Wetterslev J, Perner A, Moller MH. Heterogeneity of treatment effect of stress ulcer prophylaxis in ICU patients: A secondary analysis protocol. Acta Anaesthesiol Scand. 2019 Oct;63(9):1251-1256. doi: 10.1111/aas.13432. Epub 2019 Jul 18.
PubMed 31321771Marker S, Krag M, Perner A, Wetterslev J, Lange T, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Schefold JC, Rasmussen BS, Elkmann T, Bestle M, Arenkiel B, Laake JH, Kamper MK, Lang M, Pawlowicz-Dworzanska MB, Karlsson S, Liisanantti J, Dey N, Knudsen H, Granholm A, Moller MH; SUP-ICU trial investigators. Pantoprazole in ICU patients at risk for gastrointestinal bleeding-1-year mortality in the SUP-ICU trial. Acta Anaesthesiol Scand. 2019 Oct;63(9):1184-1190. doi: 10.1111/aas.13436. Epub 2019 Jul 19.
PubMed 31282567Marker S, Perner A, Wetterslev J, Krag M, Lange T, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Schefold JC, Moller MH; SUP-ICU investigators. Pantoprazole prophylaxis in ICU patients with high severity of disease: a post hoc analysis of the placebo-controlled SUP-ICU trial. Intensive Care Med. 2019 May;45(5):609-618. doi: 10.1007/s00134-019-05589-y. Epub 2019 Mar 12.
PubMed 30863936Krag M, Marker S, Perner A, Wetterslev J, Wise MP, Schefold JC, Keus F, Guttormsen AB, Bendel S, Borthwick M, Lange T, Rasmussen BS, Siegemund M, Bundgaard H, Elkmann T, Jensen JV, Nielsen RD, Liboriussen L, Bestle MH, Elkjaer JM, Palmqvist DF, Backlund M, Laake JH, Badstolokken PM, Gronlund J, Breum O, Walli A, Winding R, Iversen S, Jarnvig IL, White JO, Brand B, Madsen MB, Quist L, Thornberg KJ, Moller A, Wiis J, Granholm A, Anthon CT, Meyhoff TS, Hjortrup PB, Aagaard SR, Andreasen JB, Sorensen CA, Haure P, Hauge J, Hollinger A, Scheuzger J, Tuchscherer D, Vuilliomenet T, Takala J, Jakob SM, Vang ML, Paelestik KB, Andersen KLD, van der Horst ICC, Dieperink W, Fjolner J, Kjer CKW, Solling C, Solling CG, Karttunen J, Morgan MPG, Sjobo B, Engstrom J, Agerholm-Larsen B, Moller MH; SUP-ICU trial group. Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU. N Engl J Med. 2018 Dec 6;379(23):2199-2208. doi: 10.1056/NEJMoa1714919. Epub 2018 Oct 24.
PubMed 30354950Krag M, Perner A, Wetterslev J, Wise MP, Borthwick M, Bendel S, Pelosi P, Keus F, Guttormsen AB, Schefold JC, Moller MH; SUP-ICU investigators. Stress ulcer prophylaxis with a proton pump inhibitor versus placebo in critically ill patients (SUP-ICU trial): study protocol for a randomised controlled trial. Trials. 2016 Apr 19;17(1):205. doi: 10.1186/s13063-016-1331-3.
PubMed 27093939
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU)
- ClinicalTrials.gov ID
- NCT02467621
- Acronym / sponsor ID
- SUP-ICU / RH-ITA-006
- Conditions
- Gastrointestinal Bleeding, Stress Ulcers
- Keywords
- Stress ulcer prophylaxis, Proton pump inhibitor, Pneumonia, Clostridium difficile infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,350 participants (actual)
- Lead sponsor
- Dr. Morten Hylander MøllerUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- Jan 2016 (actual)
- Primary completion
- 22 Oct 2017 (actual)
- Study completion
- 21 Jan 2018 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Posted 7 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton pump inhibitor (PPI) | Experimental | Drug: PantoprazolePantoprazole 40 mg |
| Normal saline | Placebo comparator | Other: Saline (0.9%)Saline (0.9%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Acute admission to the ICU
- Age ≥ 18 years
- One or more of the following risk factors:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PantoprazoleAlso: Pantoloc40 mg x 1 daily intravenously from ICU admission to ICU discharge | Drug | Proton pump inhibitor (PPI) |
| Saline (0.9%)10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge | Other | Normal saline |
Primary outcome
Mortality
Time frame: 90 days
Landmark mortality 90-days after randomization
7 secondary outcomes
Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia
Time frame: 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 Infectious Adverse Events
Time frame: Until ICU discharge, maximum 90 days
Mortality
Time frame: 1 year
Percentage of Days Alive Without Organ Support
Time frame: Within 90 days
Number of Serious Adverse Reactions
Time frame: Until ICU discharge, maximum 90 days
A Health Economic Analysis
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24141808Krag M, Perner A, Wetterslev J, Wise MP, Hylander Moller M. Stress ulcer prophylaxis versus placebo or no prophylaxis in critically ill patients. A systematic review of randomised clinical trials with meta-analysis and trial sequential analysis. Intensive Care Med. 2014 Jan;40(1):11-22. doi: 10.1007/s00134-013-3125-3. Epub 2013 Oct 19.
- Background: PubMed 25860444Krag M, Perner A, Wetterslev J, Wise MP, Borthwick M, Bendel S, McArthur C, Cook D, Nielsen N, Pelosi P, Keus F, Guttormsen AB, Moller AD, Moller MH; SUP-ICU co-authors. Prevalence and outcome of gastrointestinal bleeding and use of acid suppressants in acutely ill adult intensive care patients. Intensive Care Med. 2015 May;41(5):833-45. doi: 10.1007/s00134-015-3725-1. Epub 2015 Apr 10.
- Derived from this study: PubMed 35122105Halling CMB, Moller MH, Marker S, Krag M, Kjellberg J, Perner A, Gyrd-Hansen D. The effects of pantoprazole vs. placebo on 1-year outcomes, resource use and employment status in ICU patients at risk for gastrointestinal bleeding: a secondary analysis of the SUP-ICU trial. Intensive Care Med. 2022 Apr;48(4):426-434. doi: 10.1007/s00134-022-06631-2. Epub 2022 Feb 5.
- Derived from this study: PubMed 31938829Granholm A, Marker S, Krag M, Zampieri FG, Thorsen-Meyer HC, Kaas-Hansen BS, van der Horst ICC, Lange T, Wetterslev J, Perner A, Moller MH. Heterogeneity of treatment effect of prophylactic pantoprazole in adult ICU patients: a post hoc analysis of the SUP-ICU trial. Intensive Care Med. 2020 Apr;46(4):717-726. doi: 10.1007/s00134-019-05903-8. Epub 2020 Jan 14.
- Derived from this study: PubMed 31441031Granholm A, Lange T, Anthon CT, Marker S, Krag M, Meyhoff TS, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Schefold JC, Wetterslev J, Perner A, Moller MH. Time to onset of gastrointestinal bleeding in the SUP-ICU trial: A pre-planned substudy. Acta Anaesthesiol Scand. 2019 Nov;63(10):1346-1356. doi: 10.1111/aas.13459. Epub 2019 Sep 11.
- Derived from this study: PubMed 31321771Granholm A, Marker S, Krag M, Zampieri FG, Thorsen-Meyer HC, Kaas-Hansen BS, van der Horst ICC, Lange T, Wetterslev J, Perner A, Moller MH. Heterogeneity of treatment effect of stress ulcer prophylaxis in ICU patients: A secondary analysis protocol. Acta Anaesthesiol Scand. 2019 Oct;63(9):1251-1256. doi: 10.1111/aas.13432. Epub 2019 Jul 18.
- Derived from this study: PubMed 31282567Marker S, Krag M, Perner A, Wetterslev J, Lange T, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Schefold JC, Rasmussen BS, Elkmann T, Bestle M, Arenkiel B, Laake JH, Kamper MK, Lang M, Pawlowicz-Dworzanska MB, Karlsson S, Liisanantti J, Dey N, Knudsen H, Granholm A, Moller MH; SUP-ICU trial investigators. Pantoprazole in ICU patients at risk for gastrointestinal bleeding-1-year mortality in the SUP-ICU trial. Acta Anaesthesiol Scand. 2019 Oct;63(9):1184-1190. doi: 10.1111/aas.13436. Epub 2019 Jul 19.
- Derived from this study: PubMed 30863936Marker S, Perner A, Wetterslev J, Krag M, Lange T, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Schefold JC, Moller MH; SUP-ICU investigators. Pantoprazole prophylaxis in ICU patients with high severity of disease: a post hoc analysis of the placebo-controlled SUP-ICU trial. Intensive Care Med. 2019 May;45(5):609-618. doi: 10.1007/s00134-019-05589-y. Epub 2019 Mar 12.
- Derived from this study: PubMed 30354950Krag M, Marker S, Perner A, Wetterslev J, Wise MP, Schefold JC, Keus F, Guttormsen AB, Bendel S, Borthwick M, Lange T, Rasmussen BS, Siegemund M, Bundgaard H, Elkmann T, Jensen JV, Nielsen RD, Liboriussen L, Bestle MH, Elkjaer JM, Palmqvist DF, Backlund M, Laake JH, Badstolokken PM, Gronlund J, Breum O, Walli A, Winding R, Iversen S, Jarnvig IL, White JO, Brand B, Madsen MB, Quist L, Thornberg KJ, Moller A, Wiis J, Granholm A, Anthon CT, Meyhoff TS, Hjortrup PB, Aagaard SR, Andreasen JB, Sorensen CA, Haure P, Hauge J, Hollinger A, Scheuzger J, Tuchscherer D, Vuilliomenet T, Takala J, Jakob SM, Vang ML, Paelestik KB, Andersen KLD, van der Horst ICC, Dieperink W, Fjolner J, Kjer CKW, Solling C, Solling CG, Karttunen J, Morgan MPG, Sjobo B, Engstrom J, Agerholm-Larsen B, Moller MH; SUP-ICU trial group. Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU. N Engl J Med. 2018 Dec 6;379(23):2199-2208. doi: 10.1056/NEJMoa1714919. Epub 2018 Oct 24.
- Derived from this study: PubMed 27093939Krag M, Perner A, Wetterslev J, Wise MP, Borthwick M, Bendel S, Pelosi P, Keus F, Guttormsen AB, Schefold JC, Moller MH; SUP-ICU investigators. Stress ulcer prophylaxis with a proton pump inhibitor versus placebo in critically ill patients (SUP-ICU trial): study protocol for a randomised controlled trial. Trials. 2016 Apr 19;17(1):205. doi: 10.1186/s13063-016-1331-3.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Hylander Møller, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
Anders Perner, MD, PhD study chair
Copenhagen University Hospital, Rigshospitalet
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pantoprazole and Saline (0.9%) in people with Gastrointestinal Bleeding and Stress Ulcers, run by Dr. Morten Hylander Møller at 33 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Denmark, Finland, Norway, Netherlands, Switzerland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02467621, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.