Clinical trial NCT01060267: Intravenous Erythromycin Before Endoscopy in Patients With Variceal Bleeding: A Randomized, Double-Blind 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Variceal Bleeding
Lead sponsor: King Abdulaziz Medical City
Sponsor class: OTHER_GOV
First posted: 2010-02-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: For upto 45 minutes from start to end of endoscopy
Secondary outcomes:
measure: 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.
timeFrame: Five to seven days of hospitalization
Other outcomes:
Locations:
city: Riyadh 11426
country: Saudi Arabia
facility: King Abdul Aziz Medical City
Study officials:
affiliation: King Abdulaziz Medical City
name: Ibrahim H Altraif, MBBS, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.