Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis

Sponsor

Far Eastern Memorial Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00839488

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Stomach Ulcer	Drug: pantoprazole 40 mg iv Drug: famotidine 20 mg iv	Phase 4

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

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis in Patients After Major Abdominal Surgery

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: I pantoprazole 40 mg iv qd	Drug: pantoprazole 40 mg iv pnatoprazole 40 mg iv qd Other Names: Pantoloc iv
Active Comparator: II famotidine 20 mg q12h	Drug: famotidine 20 mg iv famotidine 20 mg q12h Other Names: gaster iv

Arm

Intervention/Treatment

Active Comparator: I

pantoprazole 40 mg iv qd

Drug: pantoprazole 40 mg iv

pnatoprazole 40 mg iv qd

Other Names:

Pantoloc iv

Active Comparator: II

famotidine 20 mg q12h

Drug: famotidine 20 mg iv

famotidine 20 mg q12h

Other Names:

gaster iv

Outcome Measures

Primary Outcome Measures

apparant upper gastrointestinal bleeding [7 days, within the interval of drug prophylaxis]

Secondary Outcome Measures

microscopic gastrointestinal bleeding, ventilator associated pneumonia [7 days, within the interval of drug prophaxis]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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