Overview

This trial is active, not recruiting.

Conditions gastrointestinal hemorrhage, hematemesis
Treatments erythromycin, gastric lavage
Phase phase 3
Sponsor Hospital Universitari de Bellvitge
Collaborator Ministerio de Sanidad, Servicios Sociales e Igualdad
Start date February 2012
End date September 2015
Trial size 122 participants
Trial identifier NCT01716572, ERITRO2011

Summary

The researchers will investigate whether erythromycin infusion is better than gastric lavage prior to emergency endoscopy to improve the quality of examination in patients with upper gastrointestinal bleeding.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
gastric lavage by nasogastric tube with 1 liter saline before the endoscopy
gastric lavage
gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy
(Active Comparator)
administration of 250mgr of erythromycin before the endoscopy
erythromycin Pantomicina Intravenosa
Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy

Primary Outcomes

Measure
Visual quality of endoscopy
time frame: The endoscopy will be recorded and subsequently it will be evaluated by two endoscopists unaware of the cleaning strategy. The recording's evaluation will be made within the first 30 days after endoscopy

Secondary Outcomes

Measure
need for a second-look endoscopy
time frame: within the first 30 days after endoscopy
need of blood transfusion
time frame: within 30 days after endoscopy
number of adverse events as a measure of safety and tolerability
time frame: within the first 30 days after endoscopy
length of hospitalisation
time frame: within the first 30 days after endoscopy
length of endoscopic procedure
time frame: within the first 30 days after endoscopy
need for arteriography or surgery
time frame: within the first 30 days after endoscopy

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - recent hematemesis (<12 hours) Exclusion Criteria: - macrolides allergy - pregnancy or lactation - treatment with terfenadine, astemizole or cyclosporine - prior gastrectomy

Additional Information

Official title Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopic Examination in Patients With Upper Gastrointestinal Bleeding. A Prospective Randomized Trial.
Principal investigator Antonio Soriano, M D, Ph D
Description The researchers will investigate whether erythromycin infusion is better than gastric lavage prior to emergency endoscopy to improve the quality of examination in patients with upper gastrointestinal bleeding. One hundred and twenty-two patients admitted within 12 hours after hematemesis will be randomly assigned to receive erythromycin infusion or gastric lavage by nasogastric tube prior to emergency endoscopy. The endoscopic procedures will be recorded on Digital Video Disc (DVD). Two endoscopists blinded to the cleansing strategy will assess the quality of examination of the upper gastrointestinal tract by using scales designed by Frossard and Avgerinos . Secondary endpoints will be the need for a second-look endoscopy, the mean number of blood units transfused, the need of surgery or arteriography, and the mean duration of hospitalization
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Hospital Universitari de Bellvitge.