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Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis
This study is currently recruiting participants.
Study NCT00839488   Information provided by Far Eastern Memorial Hospital
First Received: February 6, 2009   No Changes Posted

February 6, 2009
February 6, 2009
April 2008
December 2010   (final data collection date for primary outcome measure)
apparant upper gastrointestinal bleeding [ Time Frame: 7 days, within the interval of drug prophylaxis ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
microscopic gastrointestinal bleeding, ventilator associated pneumonia [ Time Frame: 7 days, within the interval of drug prophaxis ] [ Designated as safety issue: Yes ]
Same as current
 
Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis
Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis in Patients After Major Abdominal Surgery

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

Phase IV
Interventional
Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Prevention
Stomach Ulcer
  • Drug: pantoprazole 40 mg iv
    pnatoprazole 40 mg iv qd
    Other Name: Pantoloc iv
  • Drug: famotidine 20 mg iv
    famotidine 20 mg q12h
    Other Name: gaster iv
  • I: Active Comparator
    pantoprazole 40 mg iv qd
    Intervention: Drug: pantoprazole 40 mg iv
  • II: Active Comparator
    famotidine 20 mg q12h
    Intervention: Drug: famotidine 20 mg iv

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
120
January 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
 
Taiwan
 
NCT00839488
Tzong-Hsi Lee, Far Eastern Memorial Hospital
FEMH-95-C-011
Far Eastern Memorial Hospital
 
Principal Investigator: Tzong Hsi Lee, MD Far Eastern Memorial Hospital
Far Eastern Memorial Hospital
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP