Metoclopramide in Upper Gastrointestinal Bleed

Sponsor

Mercy Health System (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05746377

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Upper GI Bleeding Bleeds Gastric Bleed Ulcer Hemorrhage Gastric Hemorrhage; Ulcer	Drug: Metoclopramide 10mg Drug: Saline	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

Randomization protocol instituted by pharmacy, patient and endoscopist blinded to treatment assignment.

Primary Purpose:

Treatment

Official Title:

Premedication With Metoclopramide in Upper Gastrointestinal Bleeds a Prospective Double Blinded Single Center Randomized Control Trial in a Small Community Hospital

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metoclopramide Given 10 mg Metoclopramide prior to Endoscopy	Drug: Metoclopramide 10mg IV Metoclopramide Other Names: Reglan
Placebo Comparator: Placebo Given saline flush prior to Endoscopy	Drug: Saline Placebo

Arm

Intervention/Treatment

Experimental: Metoclopramide

Given 10 mg Metoclopramide prior to Endoscopy

Drug: Metoclopramide 10mg

IV Metoclopramide

Other Names:

Reglan

Placebo Comparator: Placebo

Given saline flush prior to Endoscopy

Drug: Saline

Placebo

Outcome Measures

Primary Outcome Measures

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

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
Endoscopy Findings [During Endoscopy Procedure]
Findings of endoscopy
Endoscopy Start and End Times [During Endoscopy Procedure]
Start and stop times of endoscopies
Number of Blood Units Transfused in 24 hours [within 24 hours after admission]
measure in units of blood transfused

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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