Bleeding, Peptic Ulcer
Conditions
Keywords
ulcer bleeding, endoscopic therapy
Brief summary
The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population. The purpose of this clinical study is to compare the efficacy and safety of intravenous and oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent bleeding. The investigators hypothesize that using IV infusion is superior to oral PPI.
Detailed description
The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population. Endoscopic stigmata in bleeding peptic ulcers are prognostic and allow risk stratification. Patients with a clean ulcer base have a \< 5% risk of rebleeding; this increases progressively with a flat spot, adherent clot, non-bleeding visible vessel and active bleeding (55%). Early endoscopy in patients with bleeding peptic ulcers selects the high risk ulcers for therapy and evaluation of adjuvant PPI use.
Interventions
• Oral Esomeprazole 40mg on Day 1, 2 and Day 3 q12h
DRUGIntravenous Esomeprazole
Esomeprazole IV 80mg loading bolus * Esomeprazole intravenous infusion 8mg/hr for 72 hours
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * Confirmed ulcer bleeding with Forrest Ia, Ib, IIa, IIb * Endoscopic hemostasis achieved * Informed consent obtained
Exclusion criteria
* No consent * Forrest II c, III (clear ulcer base/flat spot and no active bleeding, i.e., minimal risk for rebleeding) * Unsuccessful endoscopic treatment (i.e., injection and/or thermal coagulation for the initial bleeding) or severe bleeding that immediate surgery is indicated * Moribund patients in whom active treatment of any form is not considered. * Polytrauma, severe injury, unconsciousness, burns, or need for continuous artificial ventilation * Upper GI malignancy or disseminated malignant disease * Esophageal varices * A Mallory-Weiss lesion * Phenytoin or theophylline treatment * Uses of PPI or H2RAs within 3 days of admission, including uses at Emergency Department N.B. Usage of aspirin or NSAID is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of clinical rebleeding within 30 day of endoscopic therapy | 30 days | Definition of clinical rebleeding 1. Recurrent hematemesis 2. fresh melena after normal stool 3. Hypotension SBP\<90 or tachycardia \>110 AND fresh melena 4. Decrease in Hb \>2g/dL (or Hct \> 10%) during any 24 h or an increas in Hb \<1 g/dL (or Hct \<3%) despite ≥4 units of blood has been transfused during any 48h |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for surgery | 30 days | — |
| Duration of hospitalization | 30 days | — |
| Blood transfusion | 30 days | — |
| Un-scheduled further endoscopic therapy | 30 days | * Un-scheduled further endoscopic therapy * Need for surgery (i.e., operation rate) * Duration of hospitalization * Blood transfusion |
| need of surgery | 30 days | — |
| un-scheduled further endoscopic therapy | 30 days | — |
| mortality | 30 days | — |
Countries
China
Outcome results
None listed