Upper GI Bleeding, Bleeds Gastric, Bleed Ulcer, Hemorrhage Gastric, Hemorrhage; Ulcer
Conditions
Keywords
metoclopramide, prokinetic, Upper endoscopy, EGD, endoscopic gastroduodenoscopy, esophagogastroduodenoscopy
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.
Interventions
IV Metoclopramide
DRUGSaline
Placebo
Sponsors
Mercy Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Randomization protocol instituted by pharmacy, patient and endoscopist blinded to treatment assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for repeat endoscopy, Interventional Radiology Intervention or Surgery due to poor visibility | 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) | During Endoscopy Procedure | Standardized 0-12 point scale for describing upper gastrointestinal tract visibility, 0 indicating poor visibility, and 12 indicating excellent visibility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glasgow-Blatchford Bleeding Score | 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 | During Endoscopy Procedure | Findings of endoscopy |
| Length of Hospital stay (days) | During Current Hospitalization (up to day 14) | Time in days between admission and discharge |
| Number of Blood Units Transfused in 24 hours | within 24 hours after admission | measure in units of blood transfused |
| Endoscopy Start and End Times | During Endoscopy Procedure | Start and stop times of endoscopies |
| Types of Adverse Neurological Side effects | 3 month f/u | Dystonia, Akathisia, Parkinsonism, Tardive Dyskinesia, Other |
Countries
United States
Contacts
Primary ContactMudassar K Sandozi, DO
Backup ContactAltaf Dawood, MD
Outcome results
None listed