Variceal Bleeding Clinical 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
Verified date | February 2010 |
Source | King Abdulaziz Medical City |
Contact | n/a |
Is FDA regulated | No |
Health authority | Saudi Arabia: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | August 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Abdul Aziz Medical City | Riyadh 11426 |
Lead Sponsor | Collaborator |
---|---|
King Abdulaziz Medical City |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | For upto 45 minutes from start to end of endoscopy | No | |
Secondary | 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. | Five to seven days of hospitalization | Yes |
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