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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
3,350
40 mg x 1 daily intravenously from ICU admission to ICU discharge
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.
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Dept. of Intensive Care, Aalborg University Hospital
Aalborg, Denmark
Dept. of Intensive Care, Århus University Hospital Nørrebrogade
Aarhus, Denmark
Dept. of Intensive Care, Århus University Hospital Skejby
Aarhus, Denmark
Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
Dept. of Neurointensive Care, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
Dept. of Intensive Care, Bispebjerg Hospital
Copenhagen, Denmark
Dept. of Intensive Care, Copenhagen University Hospital Herlev
Herlev, Denmark
Dept. of Intensive Care, Herning Hospital
Herning, Denmark
Dept. of Intensive Care, Hillerød Hospital
Hillerød, Denmark
Dept. of Intensive Care, Hjørring Hospital
Hjørring, Denmark
...and 23 more locations
Time frame: Until ICU discharge, maximum 90 days
A Health Economic Analysis
This has not been completed yet.
Time frame: 90 days