ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02467621
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : January 23, 2018
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

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 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


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




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


Secondary Outcome Measures :
  1. Proportion of patients 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 proportion of patients with one or more of the mentioned conditions in the ICU

  2. Proportion of patients with clinically important GI bleeding [ Time Frame: Until ICU discharge, maximum 90 days ]
    Proportion of patients with one or more episodes of clinically important GI bleeding in the ICU

  3. Proportion of patients with one or more infectious adverse events [ Time Frame: Until ICU discharge, maximum 90 days ]
    Proportion of patients with one or more episodes of pneumonia or clostridium difficile infection in the ICU

  4. Mortality [ Time Frame: 1 year ]
    Landmark mortality 1 year after randomization

  5. 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 ]
    The analytic details will be based on the results of the trial and specified (cost-benefit vs cost-minimisation analyses).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Denmark
Dept. of Intensive Care, Aalborg University Hospital
Aalborg, Denmark, 9000
Dept. of Intensive Care, Århus University Hospital Nørrebrogade
Aarhus, Denmark, 8000
Dept. of Intensive Care, Århus University Hospital Skejby
Arhus, Denmark, 8000
Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, 2100
Dept. of Neurointensive Care, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, 2100
Dept. of Intensive Care, Bispebjerg Hospital
Copenhagen, Denmark, 2400
Dept. of Intensive Care, Copenhagen University Hospital Herlev
Herlev, Denmark, 2730
Dept. of Intensive Care, Herning Hospital
Herning, Denmark, 7400
Dept. of Intensive Care, Hillerød Hospital
Hillerød, Denmark, 3400
Dept. of Intensive Care, Hjørring Hospital
Hjørring, Denmark, 9800
Dept. of Intensive Care, Holbæk Hospital
Holbæk, Denmark, 4300
Dept. of Intensive Care, Holstebro Hospital
Holstebro, Denmark, 7500
Dept. of Intensive Care, Køge University Hospital
Køge, Denmark, 4600
Dept. of Intensive Care, Nykøbing Falster Sygehus
Nykøbing Falster, Denmark, 4800
Dept. of Intensive Care, Randers Hospital
Randers, Denmark, 8930
Dept. of Intensive Care, Roskilde Hospital
Roskilde, Denmark, 4000
Dept. of Intensive Care, Slagelse Hospital
Slagelse, Denmark, 4200
Dept. of Intensive Care, Vejle Hospital
Vejle, Denmark, 7100
Dept. of Intensive Care, Viborg Hospital
Viborg, Denmark, 8800
Finland
Dept. of Intensive Care, Helsinki University Hospital
Helsinki, Finland, 00120
Dept. of Intensive Care, Kuopio University Hospital
Kuopio, Finland, 70029
Dept. of Intensive Care, Oulu University Hospital
Oulu, Finland, 90210
Dept. of Intensive Care, Tampere University Hospital
Tampere, Finland, 33520
Dept. of Intensive Care, Turku University Hospital
Turku, Finland, 20521
Netherlands
Dept. of Intensive Care, University Medical Center Groningen
Groningen, Netherlands, 9713
Dept. of Intensive Care, Heerlen Hospital
Heerlen, Netherlands, 6419
Norway
Dept. of Intensive Care, Bergen University Hospital
Bergen, Norway, 5021
Dept. of Intensive Care, Akershus University Hospital
Lørenskog, Norway, 1478
Dept. of Intensive Care, Oslo University Hospital
Oslo, Norway, 0450
Dept. of Intensive Care, Stavanger University Hospital
Stavanger, Norway, 4011
Switzerland
Dept. of Intensive Care, Basel University Hospital
Basel, Switzerland, 4056
Dept. of Intensive Care, Bern University Hospital
Bern, Switzerland, 3010
United Kingdom
Dept. of Intensive Care, University Hospital of Wales
Cardiff, United Kingdom
Sponsors and Collaborators
Dr. Morten Hylander Møller
Rigshospitalet, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
Investigators
Principal Investigator: Morten Hylander Møller, MD, PhD Rigshospitalet, Denmark
Study Chair: Anders Perner, MD, PhD Rigshospitalet, Denmark

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Morten Hylander Møller, Principal investigator, Scandinavian Critical Care Trials Group
ClinicalTrials.gov Identifier: NCT02467621     History of Changes
Other Study ID Numbers: RH-ITA-006
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
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:
Ulcer
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Hemorrhage
Pantoprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action