Pantoprazole
Drug40 mg x 1 daily intravenously from ICU admission to ICU discharge
Other names: Pantoloc
NCT Number: NCT02467621
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Dept. of Intensive Care, Aalborg University Hospital, Aalborg, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
40 mg x 1 daily intravenously from ICU admission to ICU discharge
Other names: Pantoloc
10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
Time frame: 90 days
Landmark mortality 90-days after randomization
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
Time frame: Until ICU discharge, maximum 90 days
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 episodes of pneumonia or clostridium difficile infection in the ICU
Time frame: 1 year
Data for landmark mortality 1 year after randomization.
Time frame: Within 90 days
Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
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.
Time frame: 90 days
This has not been completed yet.
Dr. Morten Hylander Møller
Other
Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU)
Acronym: SUP-ICU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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