Metoclopramide in Upper Gastrointestinal Bleed

Overview

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 Title of Study: “Premedication With Metoclopramide in Upper Gastrointestinal Bleeds a Prospective Double Blinded Single Center Randomized Control Trial in a Small Community Hospital”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: February 2024

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.

Interventions

  • Drug: Metoclopramide 10mg
    • IV Metoclopramide
  • Drug: Saline
    • Placebo

Arms, Groups and Cohorts

  • Experimental: Metoclopramide
    • Given 10 mg Metoclopramide prior to Endoscopy
  • Placebo Comparator: Placebo
    • Given saline flush prior to Endoscopy

Clinical Trial Outcome Measures

Primary Measures

  • Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility
    • Time Frame: 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)
    • Time Frame: During Endoscopy Procedure
    • Standardized 0-12 point scale for describing upper gastrointestinal tract visibility, 0 indicating poor visibility, and 12 indicating excellent visibility

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mercy Health System
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mudassar Sandozi, Principal Investigator – Mercy Health System
  • Overall Contact(s)
    • Mudassar K Sandozi, DO, (815) 971-2544, msandozi@mhemail.org

References

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.

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