Metoclopramide in Upper Gastrointestinal Bleed

Upper GI Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746377
• Other study ID #: #323
• Status: Recruiting
• Phase: Phase 4
• Start date: May 20, 2023
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Mercy Health System
• Contact: Mudassar K Sandozi, DO
• Phone: (815) 971-2544
• Email: msandozi[@]mhemail.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Ulcer
• Upper GI Bleeding

Intervention

Drug:
• Metoclopramide 10mg
IV Metoclopramide
• Saline
Placebo

Locations

Country	Name	City	State
United States	Javon Bea Hospital-Riverside - MercyHealth	Rockford	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Health System

Country where clinical trial is conducted

United States, 

References & Publications (5)

Barkun AN, Bardou M, Martel M, Gralnek IM, Sung JJ. Prokinetics in acute upper GI bleeding: a meta-analysis. Gastrointest Endosc. 2010 Dec;72(6):1138-45. doi: 10.1016/j.gie.2010.08.011. — View Citation

Daram SR, Garretson R. Erythromycin is preferable to metoclopramide as a prokinetic in acute upper GI bleeding. Gastrointest Endosc. 2011 Jul;74(1):234; author reply 234-5. doi: 10.1016/j.gie.2011.01.059. No abstract available. — View Citation

Khan R, Gimpaya N, Vargas JI, Ramkissoon A, Seleq S, Gholami R, Akhtar HJ, Bansal R, Scaffidi MA, Amin S, Bollipo S, Kral J, Lui R, Pawlak KM, Sandhu DS, Bilal M, de-Madaria E, Siau K, Charabaty A, Hashim A, Sanchez-Luna SA, Teshima CW, May GR, Mosko JD, Walsh CM, Grover SC. The Toronto Upper Gastrointestinal Cleaning Score: a prospective validation study. Endoscopy. 2023 Feb;55(2):121-128. doi: 10.1055/a-1865-4180. Epub 2022 May 31. — View Citation

Laine L, Barkun AN, Saltzman JR, Martel M, Leontiadis GI. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding. Am J Gastroenterol. 2021 May 1;116(5):899-917. doi: 10.14309/ajg.0000000000001245. Erratum In: Am J Gastroenterol. 2021 Nov 1;116(11):2309. — View Citation

Metoclopramide for Acute Upper GI Bleeding - Tabular View - ClinicalTrials.Gov. https://clinicaltrials.gov/ct2/show/record/NCT04771481. Accessed 7 Feb. 2023.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility	Will collect if repeat procedure occurred due to poor visibility (True/False)	During Current Hospitalization (up to day 14)
Primary	Toronto Upper Gastroenterology Cleaning Score (TUGS)	Standardized 0-12 point scale for describing upper gastrointestinal tract visibility, 0 indicating poor visibility, and 12 indicating excellent visibility	During Endoscopy Procedure
Secondary	Length of Hospital stay (days)	Time in days between admission and discharge	During Current Hospitalization (up to day 14)
Secondary	Types of Adverse Neurological Side effects	Dystonia, Akathisia, Parkinsonism, Tardive Dyskinesia, Other	3 month f/u
Secondary	Glasgow-Blatchford Bleeding Score	Score from 0-29 estimating risk of gastrointestinal bleed and need for inpatient admission, 0 indicating low risk, 29 indicating high risk of mortality	within 3 hours after admission
Secondary	Endoscopy Findings	Findings of endoscopy	During Endoscopy Procedure
Secondary	Endoscopy Start and End Times	Start and stop times of endoscopies	During Endoscopy Procedure
Secondary	Number of Blood Units Transfused in 24 hours	measure in units of blood transfused	within 24 hours after admission