Skip to main content
Clinical Trials/NCT00839488
NCT00839488TerminatedPhase 4

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

Far Eastern Memorial Hospital1 site in 1 country6 target enrollmentStarted: April 2008Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Terminated
Enrollment
6
Locations
1
Primary Endpoint
apparant upper gastrointestinal bleeding

Study Overview

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

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
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

Arms & Interventions

I

Active Comparator

pantoprazole 40 mg iv qd

Intervention: pantoprazole 40 mg iv (Drug)

II

Active Comparator

famotidine 20 mg q12h

Intervention: famotidine 20 mg iv (Drug)

Outcomes

Primary Outcomes

apparant upper gastrointestinal bleeding

Time Frame: 7 days, within the interval of drug prophylaxis

Secondary Outcomes

  • microscopic gastrointestinal bleeding, ventilator associated pneumonia(7 days, within the interval of drug prophaxis)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tzong-Hsi Lee

Chief of Division of Hepatology and Gastroenterology

Far Eastern Memorial Hospital

Study Sites (1)

Loading locations...

Similar Trials