Metoclopramide for Acute Upper GI Bleeding

Sponsor

King Chulalongkorn Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04771481

Collaborator

(none)

Enrollment

Locations

Arms

22.7

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The presence of blood clot in stomach limited quality of endoscopic view ,which affect successful rate of hemostatic endoscopy in patient with acute upper gastrointestinal bleeding. The study is aimed to evaluate the efficacy of metoclopramide, as pro-kinetic agent ,for gastric visualization in the patient with acute UGIB; double-blind randomized controlled trial and two centers study. The patient were randomly assigned to receive either metoclopramide (10mg) intravenously or placebo before endoscopy 30-120 min. The primary endpoint was endoscopic yield, assessed by objective gastric visualized scoring systems. Secondary end points include duration of endoscope, technical success rate, the need for second-look EGD, units of blood transfusion, length of hospital stay and 30-day rebleeding rate.

Condition or Disease	Intervention/Treatment	Phase
Acute Upper Gastrointestinal Bleeding Effect of Drug	Drug: Metoclopramide Drug: Normal Saline 10 mL Injection	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Efficacy of Metoclopramide for Gastric Visualization by Endoscopy in Patients With Acute Upper Gastrointestinal Bleeding: Double-blind Randomized Controlled Trial

Actual Study Start Date :

Apr 10, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: metoclopramide Metoclopramide 10mg with normal saline up to 10 ml IV slowly push in 5minutes.	Drug: Metoclopramide metoclopramide 10 mg intravenous form
Placebo Comparator: placebo Normal saline 10 ml IV slowly push in 5 minutes.	Drug: Normal Saline 10 mL Injection Normal saline 10 ml intravenous form

Arm

Intervention/Treatment

Experimental: metoclopramide

Metoclopramide 10mg with normal saline up to 10 ml IV slowly push in 5minutes.

Drug: Metoclopramide

metoclopramide 10 mg intravenous form

Placebo Comparator: placebo

Normal saline 10 ml IV slowly push in 5 minutes.

Drug: Normal Saline 10 mL Injection

Normal saline 10 ml intravenous form

Outcome Measures

Primary Outcome Measures

the efficacy of metoclopramide for gastric visualization by endoscopy in patients with acute upper gastrointestinal bleeding [up to 2 hour]
assess by objective gastric visualised scoring system

Secondary Outcome Measures

duration of endoscopy [up to 1 hour]
duration of endoscopy
units of red cell transfusion [up to 30 days]
units of red cell transfusion
the need of second-look EGD [72 hours and 30days after index EGD]
the need of second-look EGD
length of hospital stay [up to 30days]
length of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age >= 18 years
Active upper GI bleeding ( defined as fresh or bright red hematemesis within 24hr. or presented of blood via NG aspiration )
Underwent upper GI endoscopy within 12hr
Informed consent obtained

Exclusion Criteria:

Known allergy of metoclopramide
History of gastric or duodenal surgery
Known case esophageal, gastric or duodenal cancer
Diagnosed with advanced HIV infection (defined as CD4 cell count <200 cells/mm3 or WHO clinical stage 3 or 4)
Pregnancy or lactating
NG lavage was done with solution > 50 ml.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King chulalongkorn memorial hospital	Bangkok	Pathum Wan	Thailand	10400
2	Division of Gastroenterology, Faculty of Medicine, Chulalongkorn University	Bangkok	Pathumwan	Thailand	10330

Sponsors and Collaborators

King Chulalongkorn Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rapat Pittayanon, MD, MSc (Medicine and Experimental Surgery) Associate Professor, Division of Gastroenterology, Faculty of Medicine, Chulalongkorn University Secretary General, the Gastroenterological Association of Thailand (GAT), King Chulalongkorn Memorial Hospital

ClinicalTrials.gov Identifier:

NCT04771481

Other Study ID Numbers:

RP021

First Posted:

Feb 25, 2021

Last Update Posted:

Apr 7, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Rapat Pittayanon, MD, MSc (Medicine and Experimental Surgery) Associate Professor, Division of Gastroenterology, Faculty of Medicine, Chulalongkorn University Secretary General, the Gastroenterological Association of Thailand (GAT), King Chulalongkorn Memorial Hospital

Metoclopramide

Acute upper gastrointestinal bleeding

Gastric visualization

Endoscopy

Additional relevant MeSH terms:

Gastrointestinal Hemorrhage

Hemorrhage

Metoclopramide

Study Results

No Results Posted as of Apr 7, 2022