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

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ClinicalTrials.gov Identifier: NCT02017379
Recruitment Status : Terminated (Could not recruit any subjects)
First Posted : December 20, 2013
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed O Othman, 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.

Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Bleeding Drug: Erythromycin Drug: Metoclopromide Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.
Study Start Date : June 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 .

  2. 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 :
  1. Source of bleeding [ Time Frame: 45 minutes ]
    Ability to identify the source of bleeding

  2. Second-look endoscopy [ Time Frame: 48 hours ]
    Need for second-look endoscopy

  3. Blood units transfused [ Time Frame: 48 hours ]
    Mean number of blood units transfused

  4. Mortality [ Time Frame: 30 days ]
    All cause mortality



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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:

  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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 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