Metoclopramide in Upper Gastrointestinal Bleed

Phase 4

Recruiting

• Conditions: Bleeds Gastric; Hemorrhage Gastric; Bleed Ulcer; Upper GI Bleeding; Hemorrhage; Ulcer
• Interventions: Drug: Metoclopramide 10mg; Drug: Saline

• Registration Number: NCT05746377
• Lead Sponsor: Mercy Health System

Brief Summary

The goal of this clinical trial is to test if metoclopramide can improve effectiveness of endoscopic intervention in upper gastrointestinal (GI) bleeds. The main questions the investigators hope to answer is

Does metoclopramide lessen the need for repeat endoscopy, interventional radiology intervention or surgery in cases of upper GI bleed?

Does metoclopramide improve visibility of the GI walls in cases of upper GI bleed?

Detailed Description

The purpose of the study is to see if giving metoclopramide prior to an endoscopy in cases of upper GI bleed can decrease the need for repeat endoscopy due to poor visibility. Metoclopramide stimulates stomach and intestine activity. It is used to treat nausea, vomiting and slow gut movement. The investigators are testing if metoclopramide's effect on stimulating stomach activity can lead to more effective emptying of blood from the stomach and upper intestines in upper GI bleeding so physicians conducting endoscopies can easily see the stomach and intestinal wall and treat the source of bleeding.

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-27
• Study Start: 2023-05-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-09
• Last Update Posted: 2023-07-11
• Primary Completion: 2024-02
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 18 and above
• Admitted to ER or inpatient services at Javon Bea Hospital MercyHealth Riverside
• Present with upper GI bleeding defined as fresh and bright red hematemesis, coffee-ground hematemesis or melena
• Plan to undergo EGD within 24 hours since admission or since first symptoms
• Calculated Glasgow-Blatchford score ≥ 2

Exclusion Criteria

• Failure to obtain informed consent
• Known allergy to metoclopramide
• Concurrent use of medications known to cause tardive dyskinesia (TD)/extrapyramidal symptoms/neuroleptic malignant syndrome
• History of TD or dystonic reaction to metoclopramide
• Pheochromocytoma, catecholamine-releasing paragangliomas
• Parkinson's Disease
• Epilepsy
• Pregnancy or lactation
• Previous gastrectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metoclopramide	Metoclopramide 10mg	Given 10 mg Metoclopramide prior to Endoscopy
Placebo	Saline	Given saline flush prior to Endoscopy

Primary Outcome Measures

Name	Time	Method
Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility	During Current Hospitalization (up to day 14)	Will collect if repeat procedure occurred due to poor visibility (True/False)
Toronto Upper Gastroenterology Cleaning Score (TUGS)	During Endoscopy Procedure	Standardized 0-12 point scale for describing upper gastrointestinal tract visibility, 0 indicating poor visibility, and 12 indicating excellent visibility

Secondary Outcome Measures

Name	Time	Method
Endoscopy Findings	During Endoscopy Procedure	Findings of endoscopy
Length of Hospital stay (days)	During Current Hospitalization (up to day 14)	Time in days between admission and discharge
Types of Adverse Neurological Side effects	3 month f/u	Dystonia, Akathisia, Parkinsonism, Tardive Dyskinesia, Other
Glasgow-Blatchford Bleeding Score	within 3 hours after admission	Score from 0-29 estimating risk of gastrointestinal bleed and need for inpatient admission, 0 indicating low risk, 29 indicating high risk of mortality
Number of Blood Units Transfused in 24 hours	within 24 hours after admission	measure in units of blood transfused
Endoscopy Start and End Times	During Endoscopy Procedure	Start and stop times of endoscopies

Trial Locations

Locations (1)

Javon Bea Hospital-Riverside - MercyHealth; 🇺🇸 Rockford, Illinois, United States