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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02017379
Other study ID # E13018
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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) -

Study Design


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
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