Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis
Primary Purpose
Stomach Ulcer
Status
Terminated
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
pantoprazole 40 mg iv
famotidine 20 mg iv
Sponsored by

About this trial
This is an interventional prevention trial for Stomach Ulcer focused on measuring pantoprazole, famotidine, stomach ulcer, digestive system surgical procedure
Eligibility 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
Sites / Locations
- Far Eastern Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
I
II
Arm Description
pantoprazole 40 mg iv qd
famotidine 20 mg q12h
Outcomes
Primary Outcome Measures
apparant upper gastrointestinal bleeding
Secondary Outcome Measures
microscopic gastrointestinal bleeding, ventilator associated pneumonia
Full Information
NCT ID
NCT00839488
First Posted
February 6, 2009
Last Updated
October 12, 2013
Sponsor
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00839488
Brief Title
Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis
Official Title
Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis in Patients After Major Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
the chief of GS left the hopsital and the successor did't want to keep on this study
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Far Eastern Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Ulcer
Keywords
pantoprazole, famotidine, stomach ulcer, digestive system surgical procedure
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Active Comparator
Arm Description
pantoprazole 40 mg iv qd
Arm Title
II
Arm Type
Active Comparator
Arm Description
famotidine 20 mg q12h
Intervention Type
Drug
Intervention Name(s)
pantoprazole 40 mg iv
Other Intervention Name(s)
Pantoloc iv
Intervention Description
pnatoprazole 40 mg iv qd
Intervention Type
Drug
Intervention Name(s)
famotidine 20 mg iv
Other Intervention Name(s)
gaster iv
Intervention Description
famotidine 20 mg q12h
Primary Outcome Measure Information:
Title
apparant upper gastrointestinal bleeding
Time Frame
7 days, within the interval of drug prophylaxis
Secondary Outcome Measure Information:
Title
microscopic gastrointestinal bleeding, ventilator associated pneumonia
Time Frame
7 days, within the interval of drug prophaxis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzong Hsi Lee, MD
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Taipei
ZIP/Postal Code
22050
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
8284001
Citation
Cook DJ, Fuller HD, Guyatt GH, Marshall JC, Leasa D, Hall R, Winton TL, Rutledge F, Todd TJ, Roy P, et al. Risk factors for gastrointestinal bleeding in critically ill patients. Canadian Critical Care Trials Group. N Engl J Med. 1994 Feb 10;330(6):377-81. doi: 10.1056/NEJM199402103300601.
Results Reference
background
PubMed Identifier
8092901
Citation
Maier RV, Mitchell D, Gentilello L. Optimal therapy for stress gastritis. Ann Surg. 1994 Sep;220(3):353-60; discussion 360-3. doi: 10.1097/00000658-199409000-00011.
Results Reference
background
PubMed Identifier
9257310
Citation
Lu WY, Rhoney DH, Boling WB, Johnson JD, Smith TC. A review of stress ulcer prophylaxis in the neurosurgical intensive care unit. Neurosurgery. 1997 Aug;41(2):416-25; discussion 425-6. doi: 10.1097/00006123-199708000-00017.
Results Reference
background
PubMed Identifier
9934901
Citation
Lam NP, Le PD, Crawford SY, Patel S. National survey of stress ulcer prophylaxis. Crit Care Med. 1999 Jan;27(1):98-103. doi: 10.1097/00003246-199901000-00034.
Results Reference
background
PubMed Identifier
8544272
Citation
Cook DJ, Reeve BK, Guyatt GH, Heyland DK, Griffith LE, Buckingham L, Tryba M. Stress ulcer prophylaxis in critically ill patients. Resolving discordant meta-analyses. JAMA. 1996 Jan 24-31;275(4):308-14.
Results Reference
background
PubMed Identifier
15061430
Citation
Allen ME, Kopp BJ, Erstad BL. Stress ulcer prophylaxis in the postoperative period. Am J Health Syst Pharm. 2004 Mar 15;61(6):588-96. doi: 10.1093/ajhp/61.6.588.
Results Reference
background
PubMed Identifier
15143910
Citation
Kantorova I, Svoboda P, Scheer P, Doubek J, Rehorkova D, Bosakova H, Ochmann J. Stress ulcer prophylaxis in critically ill patients: a randomized controlled trial. Hepatogastroenterology. 2004 May-Jun;51(57):757-61.
Results Reference
background
PubMed Identifier
9339962
Citation
Tryba M, Cook D. Current guidelines on stress ulcer prophylaxis. Drugs. 1997 Oct;54(4):581-96. doi: 10.2165/00003495-199754040-00005.
Results Reference
background
PubMed Identifier
8420726
Citation
Martin LF, Booth FV, Karlstadt RG, Silverstein JH, Jacobs DM, Hampsey J, Bowman SC, D'Ambrosio CA, Rockhold FW. Continuous intravenous cimetidine decreases stress-related upper gastrointestinal hemorrhage without promoting pneumonia. Crit Care Med. 1993 Jan;21(1):19-30. doi: 10.1097/00003246-199301000-00009.
Results Reference
background
PubMed Identifier
2891032
Citation
Driks MR, Craven DE, Celli BR, Manning M, Burke RA, Garvin GM, Kunches LM, Farber HW, Wedel SA, McCabe WR. Nosocomial pneumonia in intubated patients given sucralfate as compared with antacids or histamine type 2 blockers. The role of gastric colonization. N Engl J Med. 1987 Nov 26;317(22):1376-82. doi: 10.1056/NEJM198711263172204.
Results Reference
background
PubMed Identifier
8431119
Citation
Fabian TC, Boucher BA, Croce MA, Kuhl DA, Janning SW, Coffey BC, Kudsk KA. Pneumonia and stress ulceration in severely injured patients. A prospective evaluation of the effects of stress ulcer prophylaxis. Arch Surg. 1993 Feb;128(2):185-91; discussion 191-2. doi: 10.1001/archsurg.1993.01420140062010.
Results Reference
background
PubMed Identifier
201091
Citation
Pal BK, Roy-Burman P. RNA tumor virus phosphoproteins: subvirion location of the multiple phosphorylated species. Virology. 1977 Dec;83(2):423-7. doi: 10.1016/0042-6822(77)90188-x. No abstract available.
Results Reference
background
PubMed Identifier
9529184
Citation
Lasky MR, Metzler MH, Phillips JO. A prospective study of omeprazole suspension to prevent clinically significant gastrointestinal bleeding from stress ulcers in mechanically ventilated trauma patients. J Trauma. 1998 Mar;44(3):527-33. doi: 10.1097/00005373-199803000-00020.
Results Reference
background
PubMed Identifier
12639176
Citation
Huggins RM, Scates AC, Latour JK. Intravenous proton-pump inhibitors versus H2-antagonists for treatment of GI bleeding. Ann Pharmacother. 2003 Mar;37(3):433-7. doi: 10.1345/aph.1C115.
Results Reference
background
PubMed Identifier
15534928
Citation
Hsu PI, Lo GH, Lo CC, Lin CK, Chan HH, Wu CJ, Shie CB, Tsai PM, Wu DC, Wang WM, Lai KH. Intravenous pantoprazole versus ranitidine for prevention of rebleeding after endoscopic hemostasis of bleeding peptic ulcers. World J Gastroenterol. 2004 Dec 15;10(24):3666-9. doi: 10.3748/wjg.v10.i24.3666.
Results Reference
background
PubMed Identifier
11110607
Citation
Trepanier EF. Intravenous pantoprazole: a new tool for acutely ill patients who require acid suppression. Can J Gastroenterol. 2000 Nov;14 Suppl D:11D-20D. doi: 10.1155/2000/608413.
Results Reference
background
Learn more about this trial
Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis
We'll reach out to this number within 24 hrs