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

Primary Purpose

Upper Gastrointestinal Bleeding

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Erythromycin
Metoclopromide
Sponsored by
Texas Tech University Health Sciences Center, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Gastrointestinal Bleeding focused on measuring upper gastrointestinal bleeding, melena, hematemesis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

    -

Sites / Locations

  • Texas Tech University Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Erythromycin

Metoclopromide

Control

Arm Description

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

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

no medications will be given prior to endoscopy

Outcomes

Primary Outcome Measures

Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa .
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
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
Ability to identify the source of bleeding
Second-look Endoscopy
Need for second-look endoscopy
Blood Units Transfused
Mean number of blood units transfused
Mortality
All cause mortality

Full Information

First Posted
December 16, 2013
Last Updated
February 10, 2021
Sponsor
Texas Tech University Health Sciences Center, El Paso
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1. Study Identification

Unique Protocol Identification Number
NCT02017379
Brief Title
Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.
Official Title
Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Could not recruit any subjects
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center, El Paso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Bleeding
Keywords
upper gastrointestinal bleeding, melena, hematemesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erythromycin
Arm Type
Experimental
Arm Description
Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure
Arm Title
Metoclopromide
Arm Type
Experimental
Arm Description
Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy
Arm Title
Control
Arm Type
No Intervention
Arm Description
no medications will be given prior to endoscopy
Intervention Type
Drug
Intervention Name(s)
Erythromycin
Other Intervention Name(s)
Erythrocin, E-Mycin, Ery-Tab, Ilosone
Intervention Type
Drug
Intervention Name(s)
Metoclopromide
Other Intervention Name(s)
Reglan, Maxolon, Metozolv ODT
Primary Outcome Measure Information:
Title
Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa .
Description
Whether erythromycin, metoclopramide versus control can enable visualization of the entire gastric mucosa .
Time Frame
45 minutes
Title
Erythromycin, Metoclopromide vs Control Improving the Quality of Stomach and Duodenum Visualization
Description
Whether erythromycin, metoclopramide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al
Time Frame
45 minutes
Secondary Outcome Measure Information:
Title
Source of Bleeding
Description
Ability to identify the source of bleeding
Time Frame
45 minutes
Title
Second-look Endoscopy
Description
Need for second-look endoscopy
Time Frame
48 hours
Title
Blood Units Transfused
Description
Mean number of blood units transfused
Time Frame
48 hours
Title
Mortality
Description
All cause mortality
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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) -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed O Othman, MD
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University Health Science Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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