Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy (lowdosePPI)

Changhua Christian Medical Foundation

Status: Withdrawn

Conditions: Peptic Ulcer Bleeding

Treatments: Device: heat probe or hemoclip

Study type: Interventional

Funder types: Other

Identifiers

NCT04407832

lowdosePPI

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

low dose PPI

Active Comparator group

Description:

40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months

Treatment:

Device: heat probe or hemoclip

Device: heat probe or hemoclip

high dose PPI

Active Comparator group

Description:

40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months

Treatment:

Device: heat probe or hemoclip

Device: heat probe or hemoclip