Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy
- Conditions
- Upper Gastrointestinal Bleeding
- Interventions
- Drug: Saline solution
- Registration Number
- NCT06077916
- Lead Sponsor
- Clinical Hospital Colentina
- Brief Summary
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.
- Detailed Description
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. Adverse venets due to medication will also be recorded carefully.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 223
- acute upper GI bleeding (<12 hours)
- prokinetics <12 hours
- allergy to azithromycin
- use of contraindicated drugs (due to interactions)
- pregnancy
- physician option
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Saline solution iv perfusion of 250 mL of 0.9% saline solution Azithromycin Saline solution iv perfusion of 500 mg azithromycin in 250 mL of 0.9% saline solution Azithromycin Azithromycin iv perfusion of 500 mg azithromycin in 250 mL of 0.9% saline solution
- Primary Outcome Measures
Name Time Method Toronto Upper Gastrointestinal Cleaning Score up to 12 hours after admission Quality of endoscopic visualization during urgent upper GI endo according to the Toronto Score (higher scores \>8/10 mean good bowel cleanliness)
Need for second look endoscopy up to 48 hours after endoscopy Physician judgement on need for repeat endoscopy due to low Toronto score
- Secondary Outcome Measures
Name Time Method Toronto Upper Gastrointestinal Cleaning Score up to 12 hours visualization quality per upper GI segment
Total hospitalization one month total duration of hospital stay
Number of blood units transfused one month Number of blood units transfused
Adverse events one month all advers events
Duration of endoscopy up to 12 hours after admission Duration of endoscopy
Score of endoscopist satisfaction on a 4-item scale up to 12 hours semiquantitative measure of satisfaction with cleanliness of the upper GI tract according to visual analog scale of 4-items
Trial Locations
- Locations (1)
Colentina Clinical Hospital
🇷🇴Bucuresti, Bucharest, Romania