Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis
Status:
Terminated
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
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