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

NCT02017379 | Terminated Results DMC

• 1 other identifier: E13018
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Gastrointestinal Bleeding

Keywords

upper gastrointestinal bleeding; melena; hematemesis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Source of Bleeding

  45 minutes

• Second-look Endoscopy

  48 hours

• Blood Units Transfused

  48 hours

• Mortality

  30 days

Study Arms (3)

Erythromycin

EXPERIMENTAL

Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure

Drug: Erythromycin

Metoclopromide

EXPERIMENTAL

Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy

Drug: Metoclopromide

Control

NO INTERVENTION

no medications will be given prior to endoscopy

Interventions

Erythromycin DRUG

Also known as: Erythrocin, E-Mycin, Ery-Tab, Ilosone

Erythromycin

Metoclopromide DRUG

Also known as: Reglan, Maxolon, Metozolv ODT

Metoclopromide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

Texas Tech University Health Science Center

El Paso, Texas, 79905, United States

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Melena; Hematemesis

Interventions

Erythromycin; Erythromycin Estolate; Metoclopramide

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Limitations and Caveats

The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.

Results Point of Contact

• Title: Research Compliance Officer
• Organization: Texas Tech University Health Sciences Center at El Paso

jackie.roberts@ttuhsc.edu

915-215-4814

Study Officials

• Mohamed O Othman, MD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 4, 2021
• Results First Posted: March 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)