Phase 4
N=3,298
Stress Ulcer Prophylaxis in the Intensive Care Unit
Gastrointestinal Bleeding · Stress Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT02467621 ↗Enrolled (actual)
3,298
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Mortality — 510; 499 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pantoprazole (Drug); Saline (0.9%) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dr. Morten Hylander Møller
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality |
610; 601 | — |
| SECONDARY Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia |
360; 372 | — |
| SECONDARY Number of Participants With Clinically Important GI Bleeding |
41; 69 | — |
| SECONDARY Number of Participants With One or More Infectious Adverse Events |
276; 279 | — |
| SECONDARY Mortality |
610; 601 | — |
| SECONDARY Percentage of Days Alive Without Organ Support |
92; 92 | — |
| SECONDARY Number of Serious Adverse Reactions |
0; 0 | — |
| SECONDARY A Health Economic Analysis |
— | — |
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.
Eligibility 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 4 mmol/l)
- Acute or chronic intermittent or continuous renal replacement therapy
- Invasive mechanical ventilation which is expected to last > 24 hours
- Coagulopathy (platelets 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 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
Data sourced from ClinicalTrials.gov (NCT02467621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.