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

NCT01060267 | Completed DMC

• 1 other identifier: RC06/019
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Variceal Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Erythromycin

ACTIVE COMPARATOR

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

Drug: Erythromycin

Placebo Group endoscopic therapy

NO INTERVENTION

Endoscopic therapy of variceal bleeding.

Drug: Placebo

Interventions

Erythromycin DRUG

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

Also known as: Macrolide Antibiotic

Erythromycin

Placebo DRUG

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

Placebo Group endoscopic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdulaziz Medical City: lead

Study Sites (1)

King Abdul Aziz Medical City

Riyadh, 22490, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 21145052 DERIVED

MeSH Terms

Interventions

Erythromycin; Macrolides

Intervention Hierarchy (Ancestors)

Polyketides; Lactones; Organic Chemicals; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Ibrahim H Altraif, MBBS, FRCP

  King Abdulaziz Medical City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 29, 2009
• First Posted: February 2, 2010
• Study Start: January 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 2, 2010

Record last verified: 2010-02

Locations

SA (1)