Intravenous Erythromycin Before Endoscopy in Patients With Variceal Bleeding: A Randomized, Double-Blind Trial
Information source: King Abdulaziz Medical City
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Variceal Bleeding
Intervention: Erythromycin (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: King Abdulaziz Medical City Official(s) and/or principal investigator(s):
Ibrahim H Altraif, MBBS, FRCP, Principal Investigator, Affiliation: King Abdulaziz Medical City
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
King Abdul Aziz Medical City, Riyadh 11426 22490, Saudi Arabia
Additional Information
Starting date: January 2007
Last updated: February 1, 2010
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