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Metoclopramide in Upper Gastrointestinal Bleed

Primary Purpose

Upper GI Bleeding, Bleeds Gastric, Bleed Ulcer

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Metoclopramide 10mg

Saline

About this trial

This is an interventional treatment trial for Upper GI Bleeding focused on measuring metoclopramide, prokinetic, Upper endoscopy, EGD, endoscopic gastroduodenoscopy, esophagogastroduodenoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Javon Bea Hospital-Riverside - MercyHealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metoclopramide

Placebo

Arm Description

Given 10 mg Metoclopramide prior to Endoscopy

Given saline flush prior to Endoscopy

Outcomes

Primary Outcome Measures

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)

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

Secondary Outcome Measures

Length of Hospital stay (days)

Time in days between admission and discharge

Types of Adverse Neurological Side effects

Dystonia, Akathisia, Parkinsonism, Tardive Dyskinesia, Other

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

Endoscopy Findings

Findings of endoscopy

Endoscopy Start and End Times

Start and stop times of endoscopies

Number of Blood Units Transfused in 24 hours

measure in units of blood transfused

Full Information

NCT ID

NCT05746377

First Posted

February 8, 2023

Last Updated

July 9, 2023

Sponsor

Mercy Health System

1. Study Identification

Unique Protocol Identification Number

NCT05746377

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 20, 2023 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mercy Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. 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?

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper GI Bleeding, Bleeds Gastric, Bleed Ulcer, Hemorrhage Gastric, Hemorrhage; Ulcer

Keywords

metoclopramide, prokinetic, Upper endoscopy, EGD, endoscopic gastroduodenoscopy, esophagogastroduodenoscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Masking Description

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

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metoclopramide

Arm Type

Experimental

Arm Description

Given 10 mg Metoclopramide prior to Endoscopy

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Given saline flush prior to Endoscopy

Intervention Type

Drug

Intervention Name(s)

Metoclopramide 10mg

Other Intervention Name(s)

Reglan

Intervention Description

IV Metoclopramide

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility

Description

Will collect if repeat procedure occurred due to poor visibility (True/False)

Time Frame

During Current Hospitalization (up to day 14)

Title

Toronto Upper Gastroenterology Cleaning Score (TUGS)

Description

Standardized 0-12 point scale for describing upper gastrointestinal tract visibility, 0 indicating poor visibility, and 12 indicating excellent visibility

Time Frame

During Endoscopy Procedure

Secondary Outcome Measure Information:

Title

Length of Hospital stay (days)

Description

Time in days between admission and discharge

Time Frame

During Current Hospitalization (up to day 14)

Title

Types of Adverse Neurological Side effects

Description

Dystonia, Akathisia, Parkinsonism, Tardive Dyskinesia, Other

Time Frame

3 month f/u

Title

Glasgow-Blatchford Bleeding Score

Description

Score from 0-29 estimating risk of gastrointestinal bleed and need for inpatient admission, 0 indicating low risk, 29 indicating high risk of mortality

Time Frame

within 3 hours after admission

Title

Endoscopy Findings

Description

Findings of endoscopy

Time Frame

During Endoscopy Procedure

Title

Endoscopy Start and End Times

Description

Start and stop times of endoscopies

Time Frame

During Endoscopy Procedure

Title

Number of Blood Units Transfused in 24 hours

Description

measure in units of blood transfused

Time Frame

within 24 hours after admission

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mudassar K Sandozi, DO

Phone

(815) 971-2544

msandozi@mhemail.org

First Name & Middle Initial & Last Name or Official Title & Degree

Altaf Dawood, MD

Phone

(815) 971-2544

adawood@mhemail.org

Facility Information:

Facility Name

Javon Bea Hospital-Riverside - MercyHealth

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Altaf Dawood

Phone

815-971-7000

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20970794

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.

Results Reference

background

PubMed Identifier

35642290

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.

Results Reference

background

PubMed Identifier

21704823

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.

Results Reference

background

PubMed Identifier

33929377

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.

Results Reference

background

Citation

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

Results Reference

background

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Metoclopramide in Upper Gastrointestinal Bleed

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