Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis
Information source: Far Eastern Memorial Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stomach Ulcer
Intervention: pantoprazole 40 mg iv (Drug); famotidine 20 mg iv (Drug)
Phase: Phase 4
Sponsored by: Far Eastern Memorial Hospital
Official(s) and/or principal investigator(s):
Tzong Hsi Lee, MD, Principal Investigator, Affiliation: Far Eastern Memorial Hospital
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
Official title: Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis in Patients After Major Abdominal Surgery
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: apparant upper gastrointestinal bleeding
Secondary outcome: microscopic gastrointestinal bleeding, ventilator associated pneumonia
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
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- age less than 18 y/o; pregnant; allergy to famotidine or pantoprazole; have had GI
Locations and Contacts
Far Eastern Memorial Hospital, Taipei 22050, Taiwan; Recruiting
Tzong-Hsi Lee, MD, Phone: 886-2-89667000, Ext: 1702, Email: email@example.com
Tzong-Hsi Lee, M.D., Principal Investigator
Far Eastern Memorial Hospital, Taipei 22050, Taiwan; Recruiting
Tzong-Hsi Lee, M.D., Phone: 886-2-89667000, Ext: 1702, Email: firstname.lastname@example.org
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.
Maier RV, Mitchell D, Gentilello L. Optimal therapy for stress gastritis. Ann Surg. 1994 Sep;220(3):353-60; discussion 360-3.
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. Review.
Lam NP, Lê PD, Crawford SY, Patel S. National survey of stress ulcer prophylaxis. Crit Care Med. 1999 Jan;27(1):98-103.
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.
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. Review.
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.
Tryba M, Cook D. Current guidelines on stress ulcer prophylaxis. Drugs. 1997 Oct;54(4):581-96. Review.
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.
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.
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.
Pal BK, Roy-Burman P. RNA tumor virus phosphoproteins: subvirion location of the multiple phosphorylated species. Virology. 1977 Dec;83(2):423-7. No abstract available.
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.
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. Review.
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.
Trépanier EF. Intravenous pantoprazole: a new tool for acutely ill patients who require acid suppression. Can J Gastroenterol. 2000 Nov;14 Suppl D:11D-20D. Review.
Starting date: April 2008
Last updated: August 8, 2010