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 bleedingNeed 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
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