Variceal Bleeding
Conditions
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.
Interventions
DRUGErythromycin
The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline
DRUGPlacebo
patients in placebo group 50ml of normal saline over 10 minutes, 1/2 hour before endoscopy.
Sponsors
King Abdulaziz Medical City
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Saudi Arabia
Outcome results
None listed