Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis

Condition(s) targeted: Stomach Ulcer

Intervention: pantoprazole 40 mg iv (Drug); famotidine 20 mg iv (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Far Eastern Memorial Hospital

Official(s) and/or principal investigator(s):
Tzong Hsi Lee, MD, Principal Investigator, Affiliation: Far Eastern Memorial Hospital

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

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: apparant upper gastrointestinal bleeding

Secondary outcome: microscopic gastrointestinal bleeding, ventilator associated pneumonia

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Far Eastern Memorial Hospital, Taipei 22050, Taiwan; Recruiting
Tzong-Hsi Lee, MD, Phone: 886-2-89667000, Ext: 1702, Email: thleekimo@yahoo.com.tw
Tzong-Hsi Lee, M.D., Principal Investigator

Far Eastern Memorial Hospital, Taipei 22050, Taiwan; Recruiting
Tzong-Hsi Lee, M.D., Phone: 886-2-89667000, Ext: 1702, Email: thleekimo@yahoo.com.tw

Related publications:

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Hsu PI, Lo GH, Lo CC, Lin CK, Chan HH, Wu CJ, Shie CB, Tsai PM, Wu DC, Wang WM, Lai KH. Intravenous pantoprazole versus ranitidine for prevention of rebleeding after endoscopic hemostasis of bleeding peptic ulcers. World J Gastroenterol. 2004 Dec 15;10(24):3666-9.

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Starting date: April 2008
Last updated: August 8, 2010