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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2009

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.

Interventions

  • Drug: Erythromycin
    • The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline
  • Drug: Placebo
    • patients in placebo group 50ml of normal saline over 10 minutes, 1/2 hour before endoscopy.

Arms, Groups and Cohorts

  • Active Comparator: Erythromycin
    • The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline
  • No Intervention: Placebo Group endoscopic therapy
    • Endoscopic therapy of variceal bleeding.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: For upto 45 minutes from start to end of endoscopy

Secondary Measures

  • 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.
    • Time Frame: Five to seven days of hospitalization

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • King Abdulaziz Medical City
  • Provider of Information About this Clinical Study
    • Dr. Ibrahim H Altraif, King Abdul Aziz Medical City, National Guard Health Affairs, Saudi Arabia.
  • Overall Official(s)
    • Ibrahim H Altraif, MBBS, FRCP, Principal Investigator, King Abdulaziz Medical City

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