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

Sponsor

King Abdulaziz Medical City (Other)

Overall Status

Completed

CT.gov ID

NCT01060267

Collaborator

(none)

102

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Variceal Bleeding	Drug: Erythromycin Drug: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Erythromycin The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline	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
No Intervention: Placebo Group endoscopic therapy Endoscopic therapy of variceal bleeding.	Drug: Placebo patients in placebo group 50ml of normal saline over 10 minutes, 1/2 hour before endoscopy.

Arm

Intervention/Treatment

Active Comparator: Erythromycin

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

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

No Intervention: Placebo Group endoscopic therapy

Endoscopic therapy of variceal bleeding.

Drug: Placebo

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

Outcome Measures

Primary Outcome 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. [For upto 45 minutes from start to end of endoscopy]

Secondary Outcome 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. [Five to seven days of hospitalization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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