Metoclopramide in Upper Gastrointestinal Bleed

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

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?

Study Overview

• Status: Recruiting
• Conditions: Upper GI Bleeding; Bleeds Gastric; Bleed Ulcer; Hemorrhage Gastric; Hemorrhage; Ulcer
• Intervention / Treatment: Drug: Saline; Drug: Metoclopramide 10mg

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mudassar K Sandozi, DO; Phone Number: (815) 971-2544; Email: msandozi@mhemail.org
• Study Contact Backup: Name: Altaf Dawood, MD; Phone Number: (815) 971-2544; Email: adawood@mhemail.org

Study Locations

• United States
  • Illinois
    • Rockford, Illinois, United States, 61114
      • Recruiting
      • Javon Bea Hospital-Riverside - MercyHealth
      • Contact: Altaf Dawood; Phone Number: 815-971-7000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital stay (days)	Time in days between admission and discharge	During Current Hospitalization (up to day 14)
Types of Adverse Neurological Side effects	Dystonia, Akathisia, Parkinsonism, Tardive Dyskinesia, Other	3 month f/u
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
Endoscopy Findings	Findings of endoscopy	During Endoscopy Procedure
Endoscopy Start and End Times	Start and stop times of endoscopies	During Endoscopy Procedure
Number of Blood Units Transfused in 24 hours	measure in units of blood transfused	within 24 hours after admission

Collaborators and Investigators

• Sponsor: Mercy Health System

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: metoclopramide; EGD; esophagogastroduodenoscopy; prokinetic; Upper endoscopy; endoscopic gastroduodenoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Ulcer; Hemorrhage; Gastrointestinal Hemorrhage; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Metoclopramide
• Other Study ID Numbers: #323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes