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| Descriptive Information Fields | |||||
| Brief Title † | Gastric pH in Critically Ill Patients | ||||
| Official Title † | Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study. | ||||
| 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. |
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| Detailed Description | Gastric pH is measured continuously for 72 hours with a pipolar microelectrode placed between 7 and 15cm below the lower esophageal sphincter. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment | ||||
| Primary Outcome Measure † | the percentage of time with gastric pH > 4 [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | median gastric pH [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ] incidence of gastrointestinal bleeding [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ] incidence of ventilator associated pneumonia [ Time Frame: ICU stay ] [ Designated as safety issue: Yes ] the percentage of time with an gastric pH > 5 [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ] |
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| Condition † | Critically Ill Patients Indication for Stress Ulcer Prophylaxis |
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| Intervention † | Drug: esomeprazole Drug: ranitidine |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 75 | ||||
| Start Date † | July 2004 | ||||
| Completion Date | June 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Austria | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00590928 | ||||
| Organization ID | 13H1-CM1 | ||||
| Secondary IDs †† | ESORAN trail | ||||
| Study Sponsor † | Medical University of Vienna | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Medical University of Vienna | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | December 26, 2007 | ||||
| Last Updated Date | December 26, 2007 | ||||
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