Trial | NCT01060267  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    erythromycin ...

  • Study Participants

    102
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.
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 Started
Jan 31
2007
Primary Completion
May 31
2009
Study Completion
Aug 31
2009
Last Update
Feb 02
2010
Estimate

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

Drug Placebo

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

Erythromycin Active Comparator

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

Placebo Group endoscopic therapy No Intervention

Endoscopic therapy of variceal bleeding.

Criteria 

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
No Results Posted