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Efficacy of Low Dose Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding

NCT03814421 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-10-22

No results posted yet for this study

Summary

We prepare this study to compare the efficacy of intermittent intravenous PPI infusion (relatively low dose PPI therapy) than continous PPI infusion method. Our hypothesis is that intermittent (40mg as a bolus injection daily for 72 hours) PPI therapy is not inferior to conventional high dose therapy.

Conditions

  • Peptic Ulcer Hemorrhage
  • Peptic Ulcer, Acute With Hemorrhage
  • Peptic Ulcer
  • Proton Pump Inhibitor Overdose

Interventions

DRUG

intermittent (40mg as a bolus injection daily for 72hours)

Current guidelines recommend an intravenous bolus dose of a proton pump inhibitor(PPI) followed by continuous PPI infusion after endoscopic therapy in patients with high-risk bleeding peptic ulcers. However, recent many studies suggests intermittent low dose PPI infusion might have equal efficacy at preventing peptic ulcer hemorrhage recurrence. So, the present investigator assumed that intermittent administration of proton pump inhibitor will not be different from administration of continuous proton pump inhibitor for the prevention of rebleeding in patients with peptic ulcer bleeding. Also, intermittent proton pump inhibitor administration in patients with high risk of rebleeding (Rockall score 6 points or more) will not be different from prevention of rebleeding compared with continuous proton pump inhibitor administration.

Sponsors & Collaborators

  • Samsung Changwon Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-15
Primary Completion
2018-12-31
Completion
2021-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03814421 on ClinicalTrials.gov