Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis

This study has been terminated.
(the chief of GS left the hopsital and the successor did't want to keep on this study)
Sponsor:
Information provided by (Responsible Party):
Tzong-Hsi Lee, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00839488
First received: February 6, 2009
Last updated: October 12, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Stomach Ulcer
Drug: pantoprazole 40 mg iv
Drug: famotidine 20 mg iv
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis in Patients After Major Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • apparant upper gastrointestinal bleeding [ Time Frame: 7 days, within the interval of drug prophylaxis ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • microscopic gastrointestinal bleeding, ventilator associated pneumonia [ Time Frame: 7 days, within the interval of drug prophaxis ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
pantoprazole 40 mg iv qd
Drug: pantoprazole 40 mg iv
pnatoprazole 40 mg iv qd
Other Name: Pantoloc iv
Active Comparator: II
famotidine 20 mg q12h
Drug: famotidine 20 mg iv
famotidine 20 mg q12h
Other Name: gaster iv

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00839488

Locations
Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan, 22050
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Tzong Hsi Lee, MD Far Eastern Memorial Hospital
  More Information

Publications:

Responsible Party: Tzong-Hsi Lee, Chief of Division of Hepatology and Gastroenterology, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00839488     History of Changes
Other Study ID Numbers: FEMH-95-C-011
Study First Received: February 6, 2009
Last Updated: October 12, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Far Eastern Memorial Hospital:
pantoprazole
famotidine
stomach ulcer
digestive system surgical procedure

Additional relevant MeSH terms:
Ulcer
Stomach Ulcer
Pathologic Processes
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pantoprazole
Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014