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

Information source: King Abdulaziz Medical City
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Variceal Bleeding

Intervention: Erythromycin (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: King Abdulaziz Medical City

Official(s) and/or principal investigator(s):
Ibrahim H Altraif, MBBS, FRCP, Principal Investigator, Affiliation: King Abdulaziz Medical City


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: 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.

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- Prior use of other prokinetic agents

- Pregnancy or lactation

Locations and Contacts

King Abdul Aziz Medical City, Riyadh 11426 22490, Saudi Arabia
Additional Information

Starting date: January 2007
Last updated: February 1, 2010

Page last updated: August 23, 2015

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