Intravenous Erythromycin Before Endoscopy in Patients With Variceal Bleeding: A Randomized, Double-Blind Trial
- Registration Number
- NCT01060267
- Lead Sponsor
- King Abdulaziz Medical City
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Group endoscopic therapy Placebo Endoscopic therapy of variceal bleeding. Erythromycin Erythromycin The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
King Abdul Aziz Medical City
🇸🇦Riyadh 11426, Saudi Arabia