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

Upper Gastrointestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02017379
• Other study ID #: E13018
• Status: Terminated
• Phase: N/A
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: February 2021
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

-

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Drug:
• Erythromycin

• Metoclopromide

Locations

Country	Name	City	State
United States	Texas Tech University Health Science Center	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Source of Bleeding	Ability to identify the source of bleeding	45 minutes
Secondary	Second-look Endoscopy	Need for second-look endoscopy	48 hours
Secondary	Blood Units Transfused	Mean number of blood units transfused	48 hours
Secondary	Mortality	All cause mortality	30 days