Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding
Information source: Lotung Poh-Ai Hospital
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peptic Ulcer Hemorrhage
Intervention: pantoprazole (Drug); pantoprazole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Lotung Poh-Ai Hospital Official(s) and/or principal investigator(s):
Hwai-jeng Lin, M.D., Principal Investigator, Affiliation: Lotung Poh-Ai Hospital
Overall contact:
Hwai-jeng Lin, M.D., Phone: 886-39543131, Ext: 5400, Email: hjlin@mail.pohai.org.tw
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.
Clinical Details
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
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: The primary end point was recurrent bleeding before discharge and within 14 days.
Secondary outcome: At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients were accepted for endoscopic therapy if a peptic ulcer with active bleeding,
a non-bleeding visible vessel (NBVV) or an adherent blood clot at the ulcer base was
observed within 24 hours of hospital admission.
Exclusion Criteria:
- If patients were pregnant
- Did not obtain initial hemostasis with endoscopic injection of epinephrine
- Did not give written informed consent
- Had bleeding tendency (platelet count < 50×109/L, serum prothrombin < 30% of normal,
or were taking anticoagulants), uremia.
Locations and Contacts
Hwai-jeng Lin, M.D., Phone: 886-39543131, Ext: 5400, Email: hjlin@mail.pohai.org.tw
Lotung Poh-Ai hospital, Yilan 26514, Taiwan; Recruiting
Hwai-jeng Lin, m.d., Phone: 88639543131, Ext: 5400, Email: hjlin@mail.pohai.org.tw
Hwai-jeng Lin, M.D., Principal Investigator
Additional Information
Starting date: May 2008
Ending date: May 2009
Last updated: January 29, 2009
|
