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

Effect of Intravenous Bolus Infusion of Erythromycin Prior to Endoscopy in Patients Presenting With Variceal Bleeding: A Prospective, Randomized, Double- Blind ,Placebo Controlled, Trial

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.

Study Overview

• Status: Completed
• Conditions: Variceal Bleeding
• Intervention / Treatment: Drug: Erythromycin; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh 11426, Saudi Arabia, 22490
    • King Abdul Aziz Medical City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Erythromycin; The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline	Drug: Erythromycin; The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline; Other Names: Macrolide Antibiotic
NO_INTERVENTION: Placebo Group endoscopic therapy; Endoscopic therapy of variceal bleeding.	Drug: Placebo; patients in placebo group 50ml of normal saline over 10 minutes, 1/2 hour before endoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary end point was to determine the effect of erythromycin on gastric cleansing and thereby quality of endoscopic visualization, reflecting the ease with which the procedure was performed in a clear stomach.	For upto 45 minutes from start to end of endoscopy

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary end points were; 1. the need for second look endoscopy & number of blood units transfused within 24 hours after initial endoscopy; 3. Incidence of endoscopy & drug related complications and length of hospital stay.	Five to seven days of hospitalization

Collaborators and Investigators

• Sponsor: King Abdulaziz Medical City
• Investigators: Principal Investigator: Ibrahim H Altraif, MBBS, FRCP, King Abdulaziz Medical City

Publications and helpful links

General Publications

• Altraif I, Handoo FA, Aljumah A, Alalwan A, Dafalla M, Saeed AM, Alkhormi A, Albekairy AK, Tamim H. Effect of erythromycin before endoscopy in patients presenting with variceal bleeding: a prospective, randomized, double-blind, placebo-controlled trial. Gastrointest Endosc. 2011 Feb;73(2):245-50. doi: 10.1016/j.gie.2010.09.043. Epub 2010 Dec 8.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): May 1, 2009
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: December 29, 2009
• First Submitted That Met QC Criteria: February 1, 2010
• First Posted (ESTIMATE): February 2, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 2, 2010
• Last Update Submitted That Met QC Criteria: February 1, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Protein Synthesis Inhibitors; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Anti-Bacterial Agents
• Other Study ID Numbers: RC06/019