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| Sponsored by: |
Medical University of Vienna |
| Information provided by: | Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00590928 |
Purpose
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.
| Condition | Intervention | Phase |
|
Critically Ill Patients Indication for Stress Ulcer Prophylaxis |
Drug: esomeprazole Drug: ranitidine |
Phase IV |
| MedlinePlus related topics: | Stress |
| ChemIDplus related topics: | Ranitidine Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Ranitidine Hydrochloride Ranitidine bismuth citrate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment |
| Official Title: | Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study. |
| Enrollment: | 75 |
| Study Start Date: | July 2004 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Active Comparator
patients with indication for stress ulcer prophylaxis and gastric pH < 4
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Drug: esomeprazole
40mg once daily
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2: Active Comparator
patients with indication for stress ulcer prophylaxis and gastric pH < 4
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Drug: ranitidine
50mg every h hours
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Gastric pH is measured continuously for 72 hours with a pipolar microelectrode placed between 7 and 15cm below the lower esophageal sphincter.
Eligibility
| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Austria | |||||
| Medical University of Vienna, Department of Medicine III, ICU | |||||
| Vienna, Austria, 1090 | |||||
| Medical University of Vienna |
| Principal Investigator: | Christian Madl, MD | Medical University of Vienna |
More Information
| Responsible Party: | Medical University of Vienna ( Christian Madl, MD ) |
| Study ID Numbers: | 13H1-CM1, ESORAN trail |
| First Received: | December 26, 2007 |
| Last Updated: | December 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00590928 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
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