Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis
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Purpose
Although stress ulcer is a complication that can cause significant mortality and morbidity in critical patients with risk factors, there is still lack of consensus about its prophylaxis. There are 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 association with nosocomial pneumonia. Recently, proton pump inhibitors were shown to have good prophylactic effects for stress ulcer. Pantoprazole (iv) is the first intravenous form of proton pump inhibitor that was approved by FDA. There are some reports about its application for treatment of peptic ulcer bleeding. It also has good acid suppression effect in patients under critical care. We expect that intravenous pantoprazole will have a role in stress ulcer prophylaxis.
We will enroll those patients that have received major abdominal surgery and admitted to surgical 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: pantoprazole 40 mg iv bolus stat and then qd ; Group II: famotidine 20 mg iv bolus stat and then q12h. We will monitor the following data: operation type & time, APACHE II score, CBC, CXR, stool character and OB test, NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopic examination 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 ventilator associated pneumonia in these 2 groups
| Condition | Intervention | Phase |
|---|---|---|
|
Stomach Ulcer |
Drug: pantoprazole 40 mg iv Drug: famotidine 20 mg iv |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis in Patients After Major Abdominal Surgery |
- apparant upper gastrointestinal bleeding [ Time Frame: 7 days, within the interval of drug prophylaxis ] [ Designated as safety issue: Yes ]
- microscopic gastrointestinal bleeding, ventilator associated pneumonia [ Time Frame: 7 days, within the interval of drug prophaxis ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: I
pantoprazole 40 mg iv qd
|
Drug: pantoprazole 40 mg iv
pnatoprazole 40 mg iv qd
Other Name: Pantoloc iv
|
|
Active Comparator: II
famotidine 20 mg q12h
|
Drug: famotidine 20 mg iv
famotidine 20 mg q12h
Other Name: gaster iv
|
Detailed Description:
Patient selection: those receive major abdominal operation (estimated postopeartive ICU stay more than 7 days); agree and give their consent(by their surrogate)within 24 hours after admissionto SICU; those are less than 18 y/o, pregnant, history of allergy to esomeprazole or famotidine, already have GI bleding are excluded Randomized to 2 groups: (1) 1st group to receuve pantoprazole 40 mg iv bolus stat and then qd, (2)2nd group to receive famotidine 20 mg iv bolus stat and then q12h;prophylactically used for 7 days; estimated enrollment of 60 patients for each group Monitoring items: recording opeartion procedure and time; APACHE II score at baseline, CBC、CXR at basleine and qod, stool OB at baseline; NG drainage、sputum、stool character, ICU routine (TPR, BP);ICU stay,mortality rate at 30 days; EGD perfomed according to decision of attending physician End points: apparant UGI bleeding(tarry stool, meatemesus, large amount(more than 60 ml) of coffee ground from NG、decrease of Hb more than 2g/dl and endoscopically proved lesion), mortality; ventilator associated pneumonia: new and persistent hazziness in CXR & examination of tracheal aspirate, judged by chest specialist
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- those recieved major abdominal surgery (estimated admission to sirgical ICU more than 7 days); give written consent and was randomized within 24 hours of admission
Exclusion Criteria:
- age less than 18 y/o; pregnant; allergy to famotidine or pantoprazole; have had GI bleeding
Contacts and Locations| Taiwan | |
| Far Eastern Memorial Hospital | Recruiting |
| Taipei, Taiwan, 22050 | |
| Contact: Tzong-Hsi Lee, MD 886-2-89667000 ext 1702 thleekimo@yahoo.com.tw | |
| Principal Investigator: Tzong-Hsi Lee, M.D. | |
| Far Eastern Memorial Hospital | Recruiting |
| Taipei, Taiwan, 22050 | |
| Contact: Tzong-Hsi Lee, M.D. 886-2-89667000 ext 1702 thleekimo@yahoo.com.tw | |
| Principal Investigator: | Tzong Hsi Lee, MD | Far Eastern Memorial Hospital |
More Information
Publications:
| Responsible Party: | Tzong-Hsi Lee, Far Eastern Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00839488 History of Changes |
| Other Study ID Numbers: | FEMH-95-C-011 |
| Study First Received: | February 6, 2009 |
| Last Updated: | August 8, 2010 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Far Eastern Memorial Hospital:
|
pantoprazole famotidine stomach ulcer digestive system surgical procedure |
Additional relevant MeSH terms:
|
Stomach Ulcer Ulcer Peptic Ulcer Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Pathologic Processes Famotidine Pantoprazole Anti-Ulcer Agents Gastrointestinal Agents |
Therapeutic Uses Pharmacologic Actions Histamine H2 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Proton Pump Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013