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

Not Applicable

Terminated

• Conditions: Upper Gastrointestinal Bleeding
• Interventions: Drug: Metoclopromide; Drug: Erythromycin

• Registration Number: NCT02017379
• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

Brief 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.

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

Study Timeline

• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-20
• Study Start: 2014-06
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2021-02
• Results First Submitted: 2021-02-10
• Results First Submitted QC: 2021-02-10
• Last Update Submitted: 2021-02-10
• Results First Posted: 2021-03-04
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Metoclopromide	Metoclopromide	Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy
Erythromycin	Erythromycin	Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure

Primary Outcome Measures

Name	Time	Method
Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa .	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Texas Tech University Health Science Center; 🇺🇸 El Paso, Texas, United States