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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 2014

Detailed Description

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:

1. Wither erythromycin, metoclopromide vs control can enable visualization of the entire gastric mucosa .

2. Wither erythromycin, metoclopromide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al

Interventions

  • Drug: Erythromycin
  • Drug: Metoclopromide

Arms, Groups and Cohorts

  • Experimental: Erythromycin
    • Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure
  • Experimental: Metoclopromide
    • Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy
  • No Intervention: Control
    • no medications will be given prior to endoscopy

Clinical Trial Outcome Measures

Primary Measures

  • erythromycin, metoclopromide vs control enabling visualization of the entire gastric mucosa .
    • Time Frame: 45 minutes
    • Whether erythromycin, metoclopramide versus control can enable visualization of the entire gastric mucosa .
  • erythromycin, metoclopromide vs control improving the quality of stomach and duodenum visualization
    • Time Frame: 45 minutes
    • Whether erythromycin, metoclopramide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al

Secondary Measures

  • Source of bleeding
    • Time Frame: 45 minutes
    • Ability to identify the source of bleeding
  • Second-look endoscopy
    • Time Frame: 48 hours
    • Need for second-look endoscopy
  • Blood units transfused
    • Time Frame: 48 hours
    • Mean number of blood units transfused
  • Mortality
    • Time Frame: 30 days
    • All cause mortality

Participating in This Clinical Trial

Inclusion Criteria

  • Adult patients (18-80)
  • who are admitted to the ICU for hematemesis, or coffee ground emesis

Exclusion Criteria

1. Patients younger than 18 yrs old or older than 80 yrs

2. Patients who refuse to consent to be in our study

3. Pregnant patients

4. Prior use of prokinetics in the last 48 hours

5. History of cardiac arrhythmia

6. Allergy to erythromycin or metoclopromide

7. Patients with QT prolongation (query 7)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Texas Tech University Health Sciences Center, El Paso
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohamed O Othman, Principal Investigator – Texas Tech University Health Sciences Center, El Paso
  • Overall Official(s)
    • Mohamed O Othman, MD, Principal Investigator, Texas Tech University Health Sciences Center

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