Trial record 7 of 9 for: "Hematemesis"

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

This study has been terminated.

(Could not recruit any subjects)

Sponsor:

Information provided by (Responsible Party):

Mohamed O Othman, Texas Tech University Health Sciences Center, El Paso

ClinicalTrials.gov Identifier:

NCT02017379

First received: December 16, 2013

Last updated: May 15, 2017

Last verified: May 2017

History of Changes

Purpose

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.

Condition	Intervention
Upper Gastrointestinal Bleeding	Drug: Erythromycin Drug: Metoclopromide


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Participant, Outcomes Assessor Primary Purpose: Treatment
Official Title:	Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.

Resource links provided by NLM:

MedlinePlus related topics: Bleeding Endoscopy Gastrointestinal Bleeding

Drug Information available for: Erythromycin Erythromycin stearate Erythromycin ethylsuccinate Erythromycin phosphate

U.S. FDA Resources

Further study details as provided by Mohamed O Othman, Texas Tech University Health Sciences Center, El Paso:

Primary Outcome 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 Outcome 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


Enrollment:	4
Study Start Date:	June 2014
Study Completion Date:	September 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Erythromycin Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure	Drug: Erythromycin Other Name: Erythrocin, E-Mycin, Ery-Tab, Ilosone
Experimental: Metoclopromide Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy	Drug: Metoclopromide Other Name: Reglan, Maxolon, Metozolv ODT
No Intervention: Control no medications will be given prior to 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:

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

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02017379

Locations


United States, Texas
Texas Tech University Health Science Center
El Paso, Texas, United States, 79905

Sponsors and Collaborators

Texas Tech University Health Sciences Center, El Paso

Investigators


Principal Investigator:	Mohamed O Othman, MD	Texas Tech University Health Sciences Center

More Information


Responsible Party:	Mohamed O Othman, Principal Investigator, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier:	NCT02017379 History of Changes
Other Study ID Numbers:	E13018
Study First Received:	December 16, 2013
Last Updated:	May 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		No

Keywords provided by Mohamed O Othman, Texas Tech University Health Sciences Center, El Paso:


upper gastrointestinal bleeding melena hematemesis

Additional relevant MeSH terms:


Hemorrhage Gastrointestinal Hemorrhage Pathologic Processes Gastrointestinal Diseases Digestive System Diseases Erythromycin Erythromycin Estolate Erythromycin Ethylsuccinate	Erythromycin stearate Anti-Bacterial Agents Anti-Infective Agents Gastrointestinal Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 14, 2017

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