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

This study has been completed.
Sponsor:
Information provided by:
King Abdulaziz Medical City
ClinicalTrials.gov Identifier:
NCT01060267
First received: December 29, 2009
Last updated: February 1, 2010
Last verified: February 2010
  Purpose

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 Intervention
Variceal Bleeding
Drug: Erythromycin
Drug: Placebo

Study Type: Interventional
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
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

Resource links provided by NLM:


Further study details as provided by King Abdulaziz Medical City:

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. [ Time Frame: For upto 45 minutes from start to end of endoscopy ] [ Designated as safety issue: No ]

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. [ Time Frame: Five to seven days of hospitalization ] [ Designated as safety issue: Yes ]

Enrollment: 102
Study Start Date: January 2007
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060267

Locations
Saudi Arabia
King Abdul Aziz Medical City
Riyadh 11426, Saudi Arabia, 22490
Sponsors and Collaborators
King Abdulaziz Medical City
Investigators
Principal Investigator: Ibrahim H Altraif, MBBS, FRCP King Abdulaziz Medical City
  More Information

No publications provided by King Abdulaziz Medical City

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Ibrahim H Altraif, King Abdul Aziz Medical City, National Guard Health Affairs, Saudi Arabia.
ClinicalTrials.gov Identifier: NCT01060267     History of Changes
Other Study ID Numbers: RC06/019
Study First Received: December 29, 2009
Last Updated: February 1, 2010
Health Authority: Saudi Arabia: Ethics Committee

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Anti-Bacterial Agents
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Erythromycin lactobionate
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014