GI Bleeding
Conditions
Keywords
oral proton pump inhibitor
Brief summary
Peptic ulcer bleeding is the most common etiology in upper gastrointestinal bleeding all over the world. After endoscopic treatment, proton pump inhibitor (PPI) is recommended to prevent re-bleeding. Intravenous PPI is recommended as a standard treatment. In the past, there were many trials showing the efficacy of high-dose oral PPI after endoscopic hemostasis but most were industrial sponsor which assessing an expensive PPI. Moreover, the number of patients in those studies were insufficient to confirm a non-inferiority outcome in term of rebleeding by using oral PPI. This study will evaluate a high-dose, local-made PPI (omeprazole) in peptic ulcer treatment after successful endoscopic hemostasis compared to standard IV PPI continuous drip in term of rebleeding, as well as 24-hour gastric pH monitoring.
Interventions
DRUGHigh-dose oral omeprazole
Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.
DRUGStandard IV PPI
Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization
Sponsors
King Chulalongkorn Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor will not know the assigned treatment.
Intervention model description
The patients with successful endoscopic hemostasis in peptic ulcer bleeding were equally randomized to either high-dose oral PPI or standard IV PPI for 3 days
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with peptic ulcer bleeding and endoscopic finding show ulcer with Forrest classification Ia (spurting haemorrhage), IIa (oozing haemorrhage), Ib (non-bleeding visible vessel) * Age \> 18 years old
Exclusion criteria
* Deny to participate * Pregnancy or lactation * Low risk peptic ulcer bleeding including clean base ulcer, flat pigmented spot * Non-peptic ulcer bleeding eg. erosive gastritis/duodenitis, Mallory Weiss tear, esophageal/gastric/duodenal varices, vascular lesions (eg. Dieulafoy) , malignant ulcer * Bleeding tendency * Terminal stage of cancer * ESRD on hemodialysis * Decompensated liver cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of 3-day peptic ulcer rebleeding | 3 days |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of 24-hour gastric pH above 6 | 3 days |
| Rate of 30-day peptic ulcer rebleeding | 30 days |
Countries
Thailand
Contacts
Primary ContactRapat Pittayanon, MD
Outcome results
None listed