A Phase 4 interventional study of pantoprazole 40 mg iv and famotidine 20 mg iv in Stomach Ulcer, sponsored by Far Eastern Memorial Hospital. Terminated at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-16.
Sponsored by Far Eastern Memorial Hospital · Phase 4, Interventional, and Prevention
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
112 studies on the registry are indexed under Stomach Ulcer; 13 are open to participants now.
This study's enrollment of 6 is below the median of 265 across 86 interventional studies indexed under Stomach Ulcer.
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pantoprazole 40 mg iv qd
Drug: pantoprazole 40 mg iv
famotidine 20 mg q12h
Drug: famotidine 20 mg iv
pnatoprazole 40 mg iv qd
Also known as: Pantoloc iv
famotidine 20 mg q12h
Also known as: gaster iv
apparant upper gastrointestinal bleeding
Time frame: 7 days, within the interval of drug prophylaxis
microscopic gastrointestinal bleeding, ventilator associated pneumonia
Time frame: 7 days, within the interval of drug prophaxis
This study is terminated, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Far Eastern Memorial Hospital