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Completed

NCT Number: NCT01060267

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

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Key information

Conditions

Variceal Bleeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdul Aziz Medical City

Riyadh, 22490, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythromycin

Drug

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

Placebo

Drug

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

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.

    Time frame: 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.

    Time frame: Five to seven days of hospitalization

Sponsors and collaborators

Lead sponsor

King Abdulaziz Medical City

Other Gov

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 2, 2010
Registry last updated
Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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