Metoclopramide in Upper Gastrointestinal Bleed

Mercy Health

Status and phase: Enrolling; Phase 4

Conditions: Bleed Ulcer; Hemorrhage Gastric; Hemorrhage; Ulcer; Bleeds Gastric; Upper GI Bleeding

Treatments: Drug: Saline; Drug: Metoclopramide 10mg

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05746377

#323

Details and patient eligibility

About

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?

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Metoclopramide

Experimental group

Description:

Given 10 mg Metoclopramide prior to Endoscopy

Treatment:

Drug: Metoclopramide 10mg

Placebo

Placebo Comparator group

Description:

Given saline flush prior to Endoscopy

Treatment:

Drug: Saline