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

Information source: Texas Tech University Health Sciences Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Upper Gastrointestinal Bleeding

Intervention: Erythromycin (Drug); Metoclopromide (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Texas Tech University Health Sciences Center

Summary

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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

Secondary outcome:

Ability to identify the source of bleeding

Need for second-look endoscopy

Mean number of blood units transfused

All cause mortality

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

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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)

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Locations and Contacts

Texas Tech University Health Science Center, El Paso, Texas 79905, United States; Recruiting
Myrna Arvizo, BMS, CIP, CHRC, Phone: 915) 215-4162, Email: myrna.arvizo@ttuhsc.edu
Mohamed Othman, MD, Principal Investigator
Marc Zuckerman, MD, Sub-Investigator
Mohamed Eloliby, MD, Sub-Investigator
Additional Information

Starting date: June 2014
Last updated: June 24, 2014

Page last updated: August 23, 2015

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