Critically Ill Patients, Indication for Stress Ulcer Prophylaxis
Conditions
Brief summary
H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. It is unknown, whether proton pump inhibitors are more effective in increasing gastric pH than H2-receptor antagonists in critically ill patients requiring stress ulcer prophylaxis.
Detailed description
Gastric pH is measured continuously for 72 hours with a pipolar microelectrode placed between 7 and 15cm below the lower esophageal sphincter.
Interventions
DRUGesomeprazole
40mg once daily
DRUGranitidine
50mg every h hours
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* critically ill patients * indication for stress ulcer prophylaxis * gastric pH \< 4
Exclusion criteria
* gastrointestinal bleeding * gastric pH \> 4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the percentage of time with gastric pH > 4 | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| median gastric pH | 72 hours |
| incidence of gastrointestinal bleeding | 72 hours |
| incidence of ventilator associated pneumonia | ICU stay |
| the percentage of time with an gastric pH > 5 | 72 hours |
Countries
Austria
Outcome results
None listed