This study will test the hypothesis that azythromycin is efficient and safe in cleansing the upper gastrointestinal tract for endoscopic examination in the case of acute bleeding.
In this study patients with upper GI bleeding will be randomzied to either i.v. azythromycin or placebo in order to evaluate the efficiency and safety of azythromycin for upper GI cleanliness during diagnostic endoscopy. A validated upper GI cleanliness score (Toronto score with values up to 10) and a visual analog scale will be used to evaluate cleanliness. Need for repeat endoscopy due to poor preparation, duration of hospitalization and requirement for blood transfusions during hospitalization will also be assessed as will any adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
224
azithromycin is reconstituted and administered according to standard prescription indications in 250 mL saline solution
placebo consisting of saline solution 250 mL is administered
Colentina Clinical Hospital
Bucharest, Bucharest, Romania
Toronto Upper Gastrointestinal Cleaning Score
Quality of endoscopic visualization during urgent upper GI endo according to the Toronto Score (higher scores \>8/12 mean good bowel cleanliness)
Time frame: up to 12 hours after admission
Need for second look endoscopy
Physician judgement on need for repeat endoscopy due to low Toronto score
Time frame: up to 48 hours after endoscopy
Toronto Upper Gastrointestinal Cleaning Score
visualization quality per upper GI segment
Time frame: up to 12 hours
Total hospitalization
total duration of hospital stay
Time frame: one month
Number of blood units transfused
Number of blood units transfused
Time frame: one month
Adverse events
all advers events
Time frame: one month
Duration of endoscopy
Duration of endoscopy
Time frame: up to 12 hours after admission
Score of endoscopist satisfaction on a 4-item scale
semiquantitative measure of satisfaction with cleanliness of the upper GI tract according to visual analog scale of 5-items
Time frame: up to 12 hours
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