Clinical Trial: Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 4 Study of Intravenous Proton Pump Inhibitor in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy- a Prospective Randomized Comparative Trial
Brief Summary: A large dose of PPI is effective in preventing peptic ulcer rebleeding. The investigators hypothesize that 40 mg/q6h pantoloc is equivalent to 8mg/h pantoloc in preventing rebleeding.
Detailed Summary:
A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients with bleeding peptic ulcers and is now recommended as the first hemostatic modality for these patients.
In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, two consensus statements and two meta-analysis. In our previous experience, we used omeprazole 160 mg /day infusion instead of 8 mg/h in these patients and obtained a good result .
The objectives of this study are to assess the outcomes of two different regimens of high dose of intravenous pantoprazole after endoscopic therapy in patients with peptic ulcer bleeding.
Sponsor: Lotung Poh-Ai Hospital
Current Primary Outcome: The primary end point was recurrent bleeding before discharge and within 14 days. [ Time Frame: About one year ]
Original Primary Outcome: Same as current
Current Secondary Outcome: At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared. [ Time Frame: about one year ]
Original Secondary Outcome: At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared. [ Time Frame: about one yr ]
Information By: Lotung Poh-Ai Hospital
Dates:
Date Received: August 7, 2008
Date Started: May 2008
Date Completion:
Last Updated: April 6, 2009
Last Verified: April 2009
