Clinical trial NCT04407832: Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy
Official title: A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Peptic Ulcer Bleeding
Keywords: hemostasis
heat probe
hemoclip
rebleeding
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
Collaborators: name: Taipei Medical University Hospital
name: Dalin Tzu Chi General Hospital
First posted: 2020-05-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.

The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.

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 receiving intravenous Proton Pump Inhibitor (PPI）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, including two consensus statements and two meta-analysis. To sustain a high intragastric pH, a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding. However, in one recent published metaanalysis found that low dose PPI may be as effective as high dose PPI in preventing further bleeding in high-risk patients. Therefore, one double blind study is needed clarify this puzzle.

We used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.

The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.

Eligibility criteria: Inclusion Criteria:

* patients with peptic ulcer bleeding with active bleeding or nonbleeding visible (initial Hb\<10, shock, or coffee grounds or blood in stomach)

Exclusion Criteria:

* age \>90y/o
* pregnant woman
* allergic to esomeprazole
* unwilling to enter this study
* bleeding tendency
* severe co-morbid illness, including cancer, hepatic failure, renal failure,

Primary outcomes:
measure: further bleeding
timeFrame: 14 days
Secondary outcomes:
measure: hospital stay
timeFrame: 30 days
measure: need of blood transfusion
timeFrame: 30 days
measure: surgical intervention
timeFrame: 30 days
measure: mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Division of Gastroenterology, TMUH
Study officials:
affiliation: Taipei Medical University Hospital
name: Hwai-jeng Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: