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 : October 3, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: Proton pump inhibitor (PPI)
Pantoprazole 40 mg
40 mg x 1 daily intravenously from ICU admission to ICU discharge
Other Name: Pantoloc
Placebo Comparator: Normal saline
Other: Saline (0.9%)
10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
- Mortality [ Time Frame: 90 days ]Landmark mortality 90-days after randomization
- 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
- 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
- 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
- Mortality [ Time Frame: 1 year ]Data for landmark mortality 1 year after randomization.
- 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
- 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.
- A Health Economic Analysis [ Time Frame: 90 days ]This has not been completed yet.
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
|Principal Investigator:||Morten Hylander Møller, MD, PhD||Rigshospitalet, Denmark|
|Study Chair:||Anders Perner, MD, PhD||Rigshospitalet, Denmark|