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

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ClinicalTrials.gov Identifier: NCT02467621
Recruitment Status : Completed
First Posted : June 10, 2015
Results First Posted : June 7, 2019
Last Update Posted : November 15, 2022
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Information provided by (Responsible Party):
Dr. Morten Hylander Møller, Scandinavian Critical Care Trials Group

Study Description
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Brief 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 the ICU.


Condition or disease Intervention/treatment Phase
Gastrointestinal Bleeding Stress Ulcers Drug: Pantoprazole Other: Saline (0.9%) Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU)
Actual Study Start Date : January 2016
Actual Primary Completion Date : October 22, 2017
Actual Study Completion Date : January 21, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Proton pump inhibitor (PPI)
Pantoprazole 40 mg
 Drug: Pantoprazole
40 mg x 1 daily intravenously from ICU admission to ICU discharge
Other Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: 90 days ]
    Landmark mortality 90-days after randomization


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467621


Locations
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Sponsors and Collaborators
Dr. Morten Hylander Møller
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Investigators
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Principal Investigator: Morten Hylander Møller, MD, PhD Rigshospitalet, Denmark
Study Chair: Anders Perner, MD, PhD Rigshospitalet, Denmark
  Study Documents (Full-Text)

Documents provided by Dr. Morten Hylander Møller, Scandinavian Critical Care Trials Group:
Study Protocol and Statistical Analysis Plan  [PDF] August 1, 2017

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Krag 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.

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Responsible Party: Dr. Morten Hylander Møller, Principal investigator, Scandinavian Critical Care Trials Group
ClinicalTrials.gov Identifier: NCT02467621    
Other Study ID Numbers: RH-ITA-006
First Posted: June 10, 2015    Key Record Dates
Results First Posted: June 7, 2019
Last Update Posted: November 15, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Dr. Morten Hylander Møller, Scandinavian Critical Care Trials Group:
Stress ulcer prophylaxis
Proton pump inhibitor
Pneumonia
Clostridium difficile infection
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Ulcer
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
 Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action