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

Primary Purpose

Variceal Bleeding

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Erythromycin
Placebo
Sponsored by
King Abdulaziz Medical City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Variceal Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • King Abdul Aziz Medical City

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Erythromycin

Placebo Group endoscopic therapy

Arm Description

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

Endoscopic therapy of variceal bleeding.

Outcomes

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.

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.

Full Information

First Posted
December 29, 2009
Last Updated
February 1, 2010
Sponsor
King Abdulaziz Medical City
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1. Study Identification

Unique Protocol Identification Number
NCT01060267
Brief Title
Intravenous Erythromycin Before Endoscopy in Patients With Variceal Bleeding: A Randomized, Double-Blind 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
King Abdulaziz Medical City

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Variceal Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erythromycin
Arm Type
Active Comparator
Arm Description
The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline
Arm Title
Placebo Group endoscopic therapy
Arm Type
No Intervention
Arm Description
Endoscopic therapy of variceal bleeding.
Intervention Type
Drug
Intervention Name(s)
Erythromycin
Other Intervention Name(s)
Macrolide Antibiotic
Intervention Description
The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
patients in placebo group 50ml of normal saline over 10 minutes, 1/2 hour before endoscopy.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim H Altraif, MBBS, FRCP
Organizational Affiliation
King Abdulaziz Medical City
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Abdul Aziz Medical City
City
Riyadh 11426
ZIP/Postal Code
22490
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
21145052
Citation
Altraif I, Handoo FA, Aljumah A, Alalwan A, Dafalla M, Saeed AM, Alkhormi A, Albekairy AK, Tamim H. Effect of erythromycin before endoscopy in patients presenting with variceal bleeding: a prospective, randomized, double-blind, placebo-controlled trial. Gastrointest Endosc. 2011 Feb;73(2):245-50. doi: 10.1016/j.gie.2010.09.043. Epub 2010 Dec 8.
Results Reference
derived

Learn more about this trial

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

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