Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis
Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis
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
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
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