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

• Sponsor: Texas Tech University Health Sciences Center, El Paso (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02017379
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Gastrointestinal Bleeding	Drug: Erythromycin; Drug: Metoclopromide	N/A

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 Design

• Study Type: Interventional
• 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: Jun 1, 2014
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 .

2. 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

1. Source of Bleeding [45 minutes]

   Ability to identify the source of bleeding

2. Second-look Endoscopy [48 hours]

   Need for second-look endoscopy

3. Blood Units Transfused [48 hours]

   Mean number of blood units transfused

4. Mortality [30 days]

   All cause mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Texas Tech University Health Sciences Center, El Paso
• ClinicalTrials.gov Identifier: NCT02017379
• Other Study ID Numbers: E13018
• First Posted: Dec 20, 2013
• Last Update Posted: Mar 4, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Keywords provided by Texas Tech University Health Sciences Center, El Paso: upper gastrointestinal bleeding; melena; hematemesis
• Additional relevant MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Erythromycin	Metoclopromide	Control
Arm/Group Description	Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure Erythromycin	Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy Metoclopromide	no medications will be given prior to endoscopy
Period Title: Overall Study
STARTED	0	0	0
COMPLETED	0	0	0
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Erythromycin	Metoclopromide	Control	Total
Arm/Group Description	Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure Erythromycin	Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy Metoclopromide	no medications will be given prior to endoscopy	Total of all reporting groups
Overall Participants	0	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Erythromycin	Metoclopromide	Control
Arm/Group Description	Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure Erythromycin	Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy Metoclopromide	no medications will be given prior to endoscopy
Measure Participants	0	0	0

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Erythromycin	Metoclopromide	Control
Arm/Group Description	Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure Erythromycin	Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy Metoclopromide	no medications will be given prior to endoscopy
Measure Participants	0	0	0

3. Secondary Outcome

Title	Source of Bleeding
Description	Ability to identify the source of bleeding
Time Frame	45 minutes

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Erythromycin	Metoclopromide	Control
Arm/Group Description	Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure Erythromycin	Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy Metoclopromide	no medications will be given prior to endoscopy
Measure Participants	0	0	0

4. Secondary Outcome

Title	Second-look Endoscopy
Description	Need for second-look endoscopy
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Erythromycin	Metoclopromide	Control
Arm/Group Description	Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure Erythromycin	Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy Metoclopromide	no medications will be given prior to endoscopy
Measure Participants	0	0	0

5. Secondary Outcome

Title	Blood Units Transfused
Description	Mean number of blood units transfused
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Erythromycin	Metoclopromide	Control
Arm/Group Description	Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure Erythromycin	Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy Metoclopromide	no medications will be given prior to endoscopy
Measure Participants	0	0	0

6. Secondary Outcome

Title	Mortality
Description	All cause mortality
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Erythromycin	Metoclopromide	Control
Arm/Group Description	Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure Erythromycin	Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy Metoclopromide	no medications will be given prior to endoscopy
Measure Participants	0	0	0

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.
Arm/Group Title	Erythromycin		Metoclopromide		Control
Arm/Group Description	Intravenous erythromycin infusion (dose: 250 mg) 30 min-60 min before procedure Erythromycin		Intravenous metoclopromide infusion (dose: 10 mg) 30-60 minutes prior to endoscopy Metoclopromide		no medications will be given prior to endoscopy
All Cause Mortality
	Erythromycin		Metoclopromide		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Erythromycin		Metoclopromide		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Erythromycin		Metoclopromide		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.