Intravenous Erythromycin Before Endoscopy in Patients With Variceal Bleeding: A Randomized, Double-Blind Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Objectives:

Blood in stomach \& oesophagus in patients with variceal bleeding often obscures the endoscopic view \& makes endoscopic intervention difficult to perform. Erythromycin, a motilin agonist induces gastric emptying. The aim of this study was to assess the effect of Erythromycin on endoscopic visibility and its outcome.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopy in Patients With Upper Gastrointestinal Bleeding

NCT01716572

Gastrointestinal Hemorrhage Hematemesis

UNKNOWN PHASE3

HDUPE 2004: Gastro-Oesophageal Haemorrhage in Emergency : Gastric Préparation to Endoscopy

NCT00259220

Upper Gastrointestinal Bleeding

COMPLETED PHASE3

Metoclopramide, Azithromycin, or Nondrug Pretreatment for UGIB to Reduce Second Endoscopy

NCT03840057

Gastro Intestinal Bleeding Upper Gastrointestinal Bleeding

UNKNOWN PHASE2

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

NCT02017379

Upper Gastrointestinal Bleeding

TERMINATED NA

Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding

NCT06437964

Cirrhosis, Liver Hypertension, Portal Variceal Hemorrhage

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Methods:

Adult patients with liver cirrhosis or stigmata of chronic liver disease presenting with hematemesis and or melena within previous 12 hours were randomized in a double blind trial to receive either 125 mg erythromycin or placebo 30 minutes before endoscopy. The primary end points were endoscopic visibility assessed by objective scoring system \& mean endoscopy duration. Secondary end points were need for repeat endoscopy and blood transfusions within 24 hours of first endoscopy , endoscopy related complications and length of hospital stay.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Variceal Bleeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Erythromycin

The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline

Group Type ACTIVE_COMPARATOR

Erythromycin

Intervention Type DRUG

The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline

Placebo Group endoscopic therapy

Endoscopic therapy of variceal bleeding.

Group Type NO_INTERVENTION

Placebo

Intervention Type DRUG

patients in placebo group 50ml of normal saline over 10 minutes, 1/2 hour before endoscopy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Erythromycin

The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline

Intervention Type DRUG

Placebo

patients in placebo group 50ml of normal saline over 10 minutes, 1/2 hour before endoscopy.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Macrolide Antibiotic

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients with liver cirrhosis or stigmata of chronic liver disease presenting with hematemesis and or melena within previous 12 hours with
* Age \>18 years
* Informed consent
* Hemodynamically stable patient at the time of endoscopy after resuscitation.

Exclusion Criteria

* Known allergy to erythromycin
* Prior gastric lavage on admission
* Current use of antiarrhythmic drugs
* Prior gastric surgery
* Previous history of cardiac arrhythmias
* Concomitant use of antihistaminic drugs with possible drug interactions with erythromycin
* Prior use of other prokinetic agents
* Pregnancy or lactation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No