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

Variceal Bleeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060267
• Other study ID #: RC06/019
• Status: Completed
• Phase: N/A
• First received: December 29, 2009
• Last updated: February 1, 2010
• Start date: January 2007
• Est. completion date: August 2009

Study information

• Verified date: February 2010
• Source: King Abdulaziz Medical City
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hemorrhage
• Variceal Bleeding

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	King Abdul Aziz Medical City	Riyadh 11426

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes