Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficiency and Safety of Intravenous Azithromycin in Preparation of Endoscopy for Upper Gastrointestinal Bleeding

Conditions
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Upper Gastrointestinal Bleeding

Intervention / Treatment
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* Drug: Azithromycin
* Drug: Saline solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>iv perfusion of 250 mL of 0.9% saline solution | Drug: Saline solution<br>* placebo consisting of saline solution 250 mL is administered<br>|
| Experimental: Azithromycin<br>iv perfusion of 500 mg azithromycin in 250 mL of 0.9% saline solution | Drug: Azithromycin<br>* azithromycin is reconstituted and administered according to standard prescription indications in 250 mL saline solution<br>Drug: Saline solution<br>* placebo consisting of saline solution 250 mL is administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Need for second look endoscopy | Physician judgement on need for repeat endoscopy due to low Toronto score | up to 48 hours after endoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toronto Upper Gastrointestinal Cleaning Score | visualization quality per upper GI segment | up to 12 hours | 
| Total hospitalization | total duration of hospital stay | one month | 
| Number of blood units transfused | Number of blood units transfused | one month | 
| Adverse events | all advers events | one month | 
| Duration of endoscopy | Duration of endoscopy | 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 4-items | up to 12 hours |