Prophylaxis of stress related gastrointestinal bleeding among critically ill patients in the intensive care unit. MedDRA version: 19.1 Level: PT Classification code 10022519 Term: Intensive care System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 19.1 Level: LLT Classification code 10071910 Term: Upper gastrointestinal bleeding System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Pantoprazol
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Pantoprazole
CAS Number: 102625-70-7
Other descriptive name: PANTOPRAZOLE
Concentration unit: mg/ml
Sponsors
Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Acute admission to the ICU AND •Aged = 18 years AND •One or more of the following risk factors: 1.Shock (continuous infusion with vasopressors or inotropes, systolic blood pressure 4 mmol/l) 2.Acute or chronic intermittent or continuous renal replacement therapy 3.Invasive mechanically ventilation which is expected to last > 24 hours. When in doubt of the forecast, the patient should be enrolled. 4.Coagulopathy (platelets 1.5 or prothrombin time (PT) > 20 seconds) documented within the last 24 hours 5.Ongoing treatment with anticoagulant drugs (prophylaxis doses excluded) 6.History of coagulopathy (platelets 1.5 or PT > 20 seconds within 6 months prior to hospital admission 7. 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1850
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess benefits and harms in the use of pantoprazole as stress ulcer prophylaxis in adult critically ill patients. ;Secondary Objective: Not applicable ;Primary end point(s): Mortality ;Timepoint(s) of evaluation of this end point: 90 days post-randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: See description in E.5.2;Secondary end point(s): •Proportion of patients with one or more of the following adverse events: clinically important gastrointestinal bleeding, pneumonia, clostridium difficile infection, or acute myocardial ischemia in the ICU •Proportion of patients with clinically significant GI bleeding in the ICU •Proportion of patients with one or more infectious adverse events (pneumonia or clostridium difficile infection) in the ICU •1-year “landmark” mortality post-randomization •Days alive without the use of mechanical ventilation, renal replacement therapy or circulatory support in the 90-day period •Number of SARs •A health economic analysis will be performed. The analytic details will be based on the result of the trial and specified (cost-benefit vs cost-minimisation analyses) | — |
Countries
Denmark, Finland, Iceland, Italy, Netherlands, Norway, Switzerland, United Kingdom
Contacts
Public ContactMorten Hylander Møller
Dept. of Intensive Care 4131, Copenhagen University Hospital Rigshospitalet
Outcome results
None listed