Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.

Study Overview
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Brief Summary
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This is a study comparing the effect of erythromycin or metoclopramide, 2 prokinetic drugs (Drugs which are known to speed up the emptying of the stomach or in other words to move the blood out of the stomach faster) given before endoscopy to patients with upper Gastrointestinal bleeding compared to patients who will not receive either of these medications before their endoscopy.

Detailed Description
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To compare the efficacy of pre-endoscopic interventions namely erythromycin, metoclopromide vs control in improving the outcomes of endoscopy in ICU patients admitted upper GI bleeding. Specific aims: Wither erythromycin, metoclopromide vs control can enable visualization of the entire gastric mucosa . Wither erythromycin, metoclopromide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al

Official Title
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Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.

Conditions
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Upper Gastrointestinal Bleeding

Intervention / Treatment
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* Drug: Erythromycin
* Drug: Metoclopromide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (18-80) who are admitted to the ICU for hematemesis, or coffee ground emesis Exclusion Criteria: Patients younger than 18 yrs old or older than 80 yrs Patients who refuse to consent to be in our study Pregnant patients Prior use of prokinetics in the last 48 hours History of cardiac arrhythmia Allergy to erythromycin or metoclopromide Patients with QT prolongation (query 7) -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erythromycin<br>Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure | Drug: Erythromycin<br> <br> * Other names: Erythrocin, E-Mycin, Ery-Tab, Ilosone;|
| Experimental: Metoclopromide<br>Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy | Drug: Metoclopromide<br> <br> * Other names: Reglan, Maxolon, Metozolv ODT;|
| No Intervention: Control<br>no medications will be given prior to endoscopy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa . | Whether erythromycin, metoclopramide versus control can enable visualization of the entire gastric mucosa . | 45 minutes | 
| Erythromycin, Metoclopromide vs Control Improving the Quality of Stomach and Duodenum Visualization | Whether erythromycin, metoclopramide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al | 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Source of Bleeding | Ability to identify the source of bleeding | 45 minutes | 
| Second-look Endoscopy | Need for second-look endoscopy | 48 hours | 
| Blood Units Transfused | Mean number of blood units transfused | 48 hours | 
| Mortality | All cause mortality | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper gastrointestinal bleeding, melena, hematemesis