Upper Gastrointestinal Bleeding
Conditions
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 as will any adverse events.
Interventions
DRUGAzithromycin
azithromycin is reconstituted and administered according to standard prescription indications in 250 mL saline solution
DRUGSaline solution
placebo consisting of saline solution 250 mL is administered
Sponsors
Clinical Hospital Colentina
Spitalul clinic judetean de urgenta Craiova
Spitalul clinic judetean de urgenta "Pius Brinzeu", Timisoara
Spitalul universitar de urgenta Elias, Bucuresti
Spitalul clinic de urgenta, Bucuresti
Spitalul clinic Judetean de Urgenta, Constanta
Spitalul Clinic de Urgenţǎ Bucureşti
Spitalul Universitar de Urgenta Militar Bucuresti
Spitalul Judetean de Urgenta Tulcea
Spitalul de Urgenta Prof. Dr. Agrippa Ionescu
Spitalul Universitar de Urgență București
Institutul de Gastroenterologie si Hepatologie Iasi
Institutul Regional de Gastroenterologie si Hepatologie Prof.dr.Octavian Fodor, Cluj
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 \>8/12 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
| Measure | Time frame | Description |
|---|---|---|
| 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 5-items |
Countries
Romania
Contacts
PRINCIPAL_INVESTIGATORBogdan Mateescu, Prof
Clinical Hospital Colentina
Outcome results
None listed