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

NCT03814421 | Unknown

• 1 other identifier: 2016-SCMC-008-00
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• rebleeding rates within 7 days

  Rebleeding was defined that endoscopy confirms that the bleeding is completely controlled and the following outcomes occur after initial vital signs are stabilized. 1. when a new hematemesis, hematochezia, occurs. 2. melena occurs and blood pressure decreases (less than 90 mmHg) or pulse rate increase (110 beats per minute) or hemoglobin decline (greater than 3 g / dL) within 24 hours.

  Within 7 days from enrollment of patient

Secondary Outcomes (4)

• Transfusion requirement

  within 7 days from enrollment of patient

• Hospital stay

  within 1 years from enrollment of patient

• Death related with Upper GI bleeding

  within 1 years from enrollment of patient

• Operation d/t Upper GI bleeding

  within 1 years from enrollment of patient

Study Arms (2)

Low dose intermittent

EXPERIMENTAL

Pantoprazole 40mg as a bolus injection daily for 72hours

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

High dose continous

ACTIVE COMPARATOR

Pantoprazole 40mg as a bolus injection followed by continuous infusion at 8mg/hr for 72hours

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

Interventions

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

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.

High dose continous; Low dose intermittent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older who had undergone gastroscopy for melena, hematochezia or hematemesis due to bleeding peptic ulcers were eligible. These eligible patients were required to have a peptic ulcer with bleeding on emergency endoscopy performed within 24 hours after hospitalization

You may not qualify if:

• refusal of endoscopy, gastrointestinal malignancy, Mallory-Weiss syndrome, variceal bleeding, bleeding d/t endoscopic procedure, small bowel bleeding, serious medical disease

Sponsors & Collaborators

• Samsung Changwon Hospital: lead

Study Sites (1)

Samsung Changwon Hospital

Changwon, Gyeongsangnam-do, 51353, South Korea

Location

Related Publications (3)

• Sung JJ, Chiu PW, Chan FKL, Lau JY, Goh KL, Ho LH, Jung HY, Sollano JD, Gotoda T, Reddy N, Singh R, Sugano K, Wu KC, Wu CY, Bjorkman DJ, Jensen DM, Kuipers EJ, Lanas A. Asia-Pacific working group consensus on non-variceal upper gastrointestinal bleeding: an update 2018. Gut. 2018 Oct;67(10):1757-1768. doi: 10.1136/gutjnl-2018-316276. Epub 2018 Apr 24.

  PMID: 29691276 BACKGROUND

• Sreedharan A, Martin J, Leontiadis GI, Dorward S, Howden CW, Forman D, Moayyedi P. Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD005415. doi: 10.1002/14651858.CD005415.pub3.

  PMID: 20614440 RESULT

• Cook D, Guyatt G. Prophylaxis against Upper Gastrointestinal Bleeding in Hospitalized Patients. N Engl J Med. 2018 Jun 28;378(26):2506-2516. doi: 10.1056/NEJMra1605507. No abstract available.

  PMID: 29949497 RESULT

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage; Peptic Ulcer

Condition Hierarchy (Ancestors)

Gastrointestinal Hemorrhage; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 24, 2019
• Study Start: April 15, 2016
• Primary Completion: December 31, 2018
• Study Completion: October 31, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

KR (1)