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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin lactobionate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014