Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Far Eastern Memorial Hospital |
---|---|
Information provided by: | Far Eastern Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00633035 |
Although stress ulcer is a complication that can cause mortality and morbidity in critical patients, there is still lack of consensus about its prophylaxis. There is also few data available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less associated nosocomial pneumonia. Recently, proton pump inhibitors were shown to have good prophylactic effects for stress ulcer. Esomeprazole, an isoform of omeprazole, has good acid suppression effect and the tablets are soluble for the use of tube feeding. Our previous study showed that there was no difference for the efficacy of stress ulcer prophylaxis between esomeprazole and sucralfate in patients admitted to medical ICU with at least one risk factor. The prevalence of nosocomial pneumonia was also similar.
We will enroll those patients that have received intracranial surgery and admitted to neurosurgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7 days within 24 hours. They are randomly allocated to 2 groups. Group I: esomeprazole 40 mg qd from NG route or orally; Group II: famotidine 20 mg iv bolus q12h. We will monitor the following data: Glasgow coma scale, APACHE II score, CBC, CXR, stool character and OB test, NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopy will be performed. We define the end point as overt bleeding, death or transfer out of ICU. We will compare the prevalence of UGI bleeding and nosocomial pneumonia in these 2 groups.
Condition | Intervention | Phase |
---|---|---|
Ulcer |
Drug: esomeprazole 40 mg Drug: famotidine 20 mg |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit |
Estimated Enrollment: | 120 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
oral esomeprazole
|
Drug: esomeprazole 40 mg
esomeprazole 40 mg po given for 7 days
|
2: Active Comparator
intravenous famotidine
|
Drug: famotidine 20 mg
famotidine 20 mg intravenous bolus q12h for 7 days
|
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tzong-Hsi Lee, M.D. | 886-2-89667000 ext 1702 | thleekimo@yahoo.com.tw |
Taiwan | |
Far Eastern Memorial Hospital | Recruiting |
Taipei, Taiwan, 22050 | |
Contact: Tzong-Hsi Lee, M.D. 886-2-8966700 ext 1702 thleekimo@yahoo.com.tw | |
Principal Investigator: Tzong-Hsi Lee, M.D. |
Principal Investigator: | Tzong-Hsi Lee, M.D. | Far Eastern Memorial Hospital, Taipei, Taiwan |
Responsible Party: | Far Eastern Memorial Hospital ( Tzong-Hsi Lee ) |
Study ID Numbers: | FEMH-94-C-016 |
Study First Received: | March 3, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00633035 History of Changes |
Health Authority: | Taiwan: Department of Health |
ulcer esomeprazole famotidine Neurosurgery |
Neurotransmitter Agents Histamine Antagonists Famotidine Ulcer Histamine phosphate |
Omeprazole Stress Histamine H2 Antagonists Histamine |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Ulcer Physiological Effects of Drugs Gastrointestinal Agents Omeprazole Histamine Agents Enzyme Inhibitors |
Pharmacologic Actions Histamine H2 Antagonists Pathologic Processes Famotidine Histamine Antagonists Therapeutic Uses Anti-Ulcer Agents |