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| Name | Class |
|---|---|
| Spitalul clinic judetean de urgenta Craiova | UNKNOWN |
| Spitalul clinic judetean de urgenta "Pius Brinzeu", Timisoara | UNKNOWN |
| Spitalul universitar de urgenta Elias, Bucuresti | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | iv perfusion of 250 mL of 0.9% saline solution |
|
| Azithromycin | Experimental | iv perfusion of 500 mg azithromycin in 250 mL of 0.9% saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | azithromycin is reconstituted and administered according to standard prescription indications in 250 mL saline solution |
|
| 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 >8/12 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bogdan Mateescu, Prof | Clinical Hospital Colentina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colentina Clinical Hospital | Bucharest | Bucharest | 020125 | Romania |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Spitalul clinic de urgenta, Bucuresti | UNKNOWN |
| Spitalul clinic Judetean de Urgenta, Constanta | UNKNOWN |
| Spitalul Clinic de Urgenţǎ Bucureşti | UNKNOWN |
| Spitalul Universitar de Urgenta Militar Bucuresti | UNKNOWN |
| Spitalul Judetean de Urgenta Tulcea | UNKNOWN |
| Spitalul de Urgenta Prof. Dr. Agrippa Ionescu | UNKNOWN |
| Spitalul Universitar de Urgență București | UNKNOWN |
| Institutul de Gastroenterologie si Hepatologie Iasi | UNKNOWN |
| Institutul Regional de Gastroenterologie si Hepatologie Prof.dr.Octavian Fodor, Cluj | UNKNOWN |
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| Saline solution | Drug | placebo consisting of saline solution 250 mL is administered |
|
| 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 5-items | up to 12 hours |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |