Upper Gastrointestinal Bleeding Clinical Trial
— CLEAN-AZOfficial title:
The Efficiency and Safety of Intravenous Azithromycin in Preparation of Endoscopy for Upper Gastrointestinal Bleeding
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.
Status | Recruiting |
Enrollment | 223 |
Est. completion date | November 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - acute upper GI bleeding (<12 hours) Exclusion Criteria: - prokinetics <12 hours - allergy to azithromycin - use of contraindicated drugs (due to interactions) - pregnancy - physician option |
Country | Name | City | State |
---|---|---|---|
Romania | Colentina Clinical Hospital | Bucuresti | Bucharest |
Lead Sponsor | Collaborator |
---|---|
Clinical Hospital Colentina |
Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toronto Upper Gastrointestinal Cleaning Score | Quality of endoscopic visualization during urgent upper GI endo according to the Toronto Score (higher scores >8/10 mean good bowel cleanliness) | up to 12 hours after admission | |
Primary | Need for second look endoscopy | Physician judgement on need for repeat endoscopy due to low Toronto score | up to 48 hours after endoscopy | |
Secondary | Toronto Upper Gastrointestinal Cleaning Score | visualization quality per upper GI segment | up to 12 hours | |
Secondary | Total hospitalization | total duration of hospital stay | one month | |
Secondary | Number of blood units transfused | Number of blood units transfused | one month | |
Secondary | Adverse events | all advers events | one month | |
Secondary | Duration of endoscopy | Duration of endoscopy | up to 12 hours after admission | |
Secondary | 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 4-items | up to 12 hours |
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