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Trial record 11 of 182 for:    ERYTHROMYCIN

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

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ClinicalTrials.gov Identifier: NCT01060267
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
King Abdulaziz Medical City

Tracking Information
First Submitted Date  ICMJE December 29, 2009
First Posted Date  ICMJE February 2, 2010
Last Update Posted Date February 2, 2010
Study Start Date  ICMJE January 2007
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Erythromycin Before Endoscopy in Patients With Variceal Bleeding: A Randomized, Double-Blind Trial
Official Title  ICMJE Effect of Intravenous Bolus Infusion of Erythromycin Prior to Endoscopy in Patients Presenting With Variceal Bleeding: A Prospective, Randomized, Double- Blind ,Placebo Controlled, Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Variceal Bleeding
Intervention  ICMJE
  • 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
  • Drug: Placebo
    patients in placebo group 50ml of normal saline over 10 minutes, 1/2 hour before endoscopy.
Study Arms  ICMJE
  • Active Comparator: Erythromycin
    The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline
    Intervention: Drug: Erythromycin
  • No Intervention: Placebo Group endoscopic therapy
    Endoscopic therapy of variceal bleeding.
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2010)
102
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01060267
Other Study ID Numbers  ICMJE RC06/019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Ibrahim H Altraif, King Abdul Aziz Medical City, National Guard Health Affairs, Saudi Arabia.
Study Sponsor  ICMJE King Abdulaziz Medical City
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ibrahim H Altraif, MBBS, FRCP King Abdulaziz Medical City
PRS Account King Abdulaziz Medical City
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP