Peptic Ulcer Clinical Trial
Official title:
Compare Gastric Acid Suppression of Esomeprazole by Oral or Intravenous Administration - A Randomized Trial
The purpose of this study is to compare the gastric acid suppression profile among different regimen (Oral Vs Intravenous)of administration of proton pump inhibitor - Esomeprazole by 24hours intragastric pH monitoring.
Peptic ulcer bleeding is a common medical emergency. Although primary hemostasis can be
achieved by endoscopic hemostasis in more than 90% of cases, rebleeding during the first 72
hours is still common. The use of secretory inhibitors in ulcer bleeding had theoretical
benefit in preventing rebleeding. In vitro, platelet aggregation and disaggregation,
coagulation and fibrinolysis are strongly dependent on intra-gastric pH. When pH falls below
6.0, platelet disaggregation takes place and below 4.0, fibrin clots dissolved.
Pharmacological studies have clearly shown that primed proton-pump inhibitor (PPI) infusion
is superior to H2-receptor blocler (H2B) injection or infusion in maintaining high
intra-gastric pH. Randomized trials had demonstrated the advantage of adjuvant use of
intravenous or oral PPI in reducing rebleeding as compared to placebo. However, as Asian
subjects generally have lower body weight and acid output than Caucasians, the dosage of PPI
required for prevent rebleeding may be different. Lin et al had demonstrated that in an
Asian population study, in order to show a significant clinical effect in prevent peptic
ulcer rebleeding after endoscopic hemostasis, at least a 30% difference in duration in
maintaining an intragastric pH >6 must be achieved. As there is substantial cost implication
of routine use of high dose intravenous PPI infusion (80mg bolus + 8mg/hour for 72 hours,
cost ~HKD$1100) against high dose oral esomeprazole (40mg BD for 3 days, cost ~HKD$60), the
optimal doses and routes of administration of PPI in achieving effective acid suppression is
needed to be clearly defined.
Protocol:
Patients presented with bleeding peptic ulcers (melena, hememtesis) will undergo endoscopy.
If clean base peptic ulcer which dos not require endoscopic treatment is diagnosed,
consented patients will randomly allocated into 2 groups using sealed envelopes containing a
therapeutic option derived from a randomized table.
1. Esomeprazole infusion (80mg bolus then 8mg/hour) (192mg/d)
2. Esomeprazole Tablet oral 40mg 12 hourly (80mg/d)
A pH electrode with internal reference (Synetic) was inserted transnasally and positioned
10cm below the cardia. It was calibrated before and after the pH recording with standard
buffer solutions of pH 7.00 and pH 1.00. The electrode was connected to a data logger
(Mircodigitrapper, Synetic). At the end of 24hours recording, the data were transfer to a
personal computer for analysis. Medication will be given after insertion of intra-gastric pH
monitor probe.
Outcome measures Primary Outcome: total % Time pH > 6 & 4 Secondary outcome: Median
intragastric pH & Time to reach pH 4 and 6
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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