A Phase 4 interventional study of Metoclopramide 10mg and Saline in Upper GI Bleeding, Bleeds Gastric and Bleed Ulcer, sponsored by Mercy Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-11.
Sponsored by Mercy Health System · Phase 4, Interventional, and Treatment
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?
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's planned enrollment of 60 is below the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Mercy Health System is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Given 10 mg Metoclopramide prior to Endoscopy
Drug: Metoclopramide 10mg
Given saline flush prior to Endoscopy
Drug: Saline
IV Metoclopramide
Also known as: Reglan
Placebo
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)
Time frame: 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
Time frame: During Endoscopy Procedure
Length of Hospital stay (days)
Time in days between admission and discharge
Time frame: During Current Hospitalization (up to day 14)
Types of Adverse Neurological Side effects
Dystonia, Akathisia, Parkinsonism, Tardive Dyskinesia, Other
Time frame: 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
Time frame: within 3 hours after admission
Endoscopy Findings
Findings of endoscopy
Time frame: During Endoscopy Procedure
Endoscopy Start and End Times
Start and stop times of endoscopies
Time frame: During Endoscopy Procedure
Number of Blood Units Transfused in 24 hours
measure in units of blood transfused
Time frame: within 24 hours after admission
Plan to share: No
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