Gastrointestinal Hemorrhage
Conditions
Keywords
24 hours pH monitoring
Brief summary
The investigators hypothesize that high dose esomeprazole 80mg given as a bolus, followed by 8mg/h would render gastric pH near neutral and that pH control with esomeprazole given in such a high dose either intravenous or orally is identical.
Detailed description
Bleeding peptic ulcer is a common and life threatening condition. Endoscopic therapy has become the mainstay of controlling bleeding. Recurrent bleeding after endoscopic control occurs in about 20% of patients with a high associated mortality. We previously demonstrated that the adjunct use of high dose proton pump inhibitor reduces risk of recurrent bleeding and thereby improves patients' outcome \[Lau JY N Engl J Med 2000\]. The newer PPI, esomeprazole, is an S-isomer of omeprazole. Esomeprazole is more effective in gastric acid control as measured by both basal and pentagastrin acid output when compared to omeprazole. Esomeprazole when given orally at a lower dose achieves a similar gastric control than intravenous esomeprazole. The gastric pH with a high dose esomeprazole when given either orally or intravenously has not been measured among Hong Kong Chinese. If a high dose oral esomeprazole achieves a similar pH control near gastric neutrality, the oral regime can be used in place of the intravenous formulation. This represents significant convenience in dosing and cost savings.
Interventions
DRUGIntravenous bolus injection of esomeprazole
80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours
40mg every 12 hours for 24 hours
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients admitted with diagnosis of upper gastrointestinal bleeding aged between 18 and 80 * Endoscopic confirmation of a bleeding duodenal or gastric ulcer to which endoscopic control has been obtained * Absence of H. pylori infection * Informed written consent
Exclusion criteria
* Known incompatibility to the study drugs; * Known incompatibility and hypersensitivity to proton pump inhibitor * H. pylori infection * Recent H2RA or PPI use (within last 4 weeks) * Concomitant use of medications that may interfere gastric acid secretion or motility (e.g. anticholinergic, metoclopramide, domperidone) * Pregnancy or lactation; * Non-compliance e.g. mental subordination * Nasopharyngeal or oropharyngeal pathology that would prevent passage of a nasal catheter * Significant liver disease as PPI is metabolized by the cytochrome P-450 system * Previous gastric surgery * Chronic Aspirin user * Presence of esophageal/ gastric varices * Moribund patients, terminal malignancy & patients with severe renal disease * Patient unable to give written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary measure of this study is the median gastric pH over 24-hour monitoring. | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| acid suppressing activity, notably the rate of onset of action, between the two treatment regimens: 1. Percentage time of pH<6 2. Time to reach pH 6 3. Median gastric pH in the first 6 and 12 hours | 24 hours |
Countries
China
Outcome results
None listed