Clinical trial NCT05746377: Metoclopramide in Upper Gastrointestinal Bleed
Official title: Premedication With Metoclopramide in Upper Gastrointestinal Bleeds a Prospective Double Blinded Single Center Randomized Control Trial in a Small Community Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Upper GI Bleeding
Bleeds Gastric
Bleed Ulcer
Hemorrhage Gastric
Hemorrhage; Ulcer
Keywords: metoclopramide
prokinetic
Upper endoscopy
EGD
endoscopic gastroduodenoscopy
esophagogastroduodenoscopy
Lead sponsor: Mercy Health System
Sponsor class: NETWORK
First posted: 2023-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility
timeFrame: During Current Hospitalization (up to day 14)
measure: Toronto Upper Gastroenterology Cleaning Score (TUGS)
timeFrame: During Endoscopy Procedure
Secondary outcomes:
measure: Length of Hospital stay (days)
timeFrame: During Current Hospitalization (up to day 14)
measure: Types of Adverse Neurological Side effects
timeFrame: 3 month f/u
measure: Glasgow-Blatchford Bleeding Score
timeFrame: within 3 hours after admission
measure: Endoscopy Findings
timeFrame: During Endoscopy Procedure
measure: Endoscopy Start and End Times
timeFrame: During Endoscopy Procedure
measure: Number of Blood Units Transfused in 24 hours
timeFrame: within 24 hours after admission
Other outcomes:
Locations:
city: Rockford
country: United States
facility: Javon Bea Hospital-Riverside - MercyHealth
state: Illinois
Study officials:
References:
citation: 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.
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.
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.
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.
citation: Metoclopramide for Acute Upper GI Bleeding - Tabular View - ClinicalTrials.Gov. https://clinicaltrials.gov/ct2/show/record/NCT04771481. Accessed 7 Feb. 2023.