Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy

Last updated: November 5, 2023
Sponsor: Clinical Hospital Colentina
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Gastric Ulcers

Gastrointestinal Diseases And Disorders

Treatment

Saline solution

Azithromycin

Clinical Study ID

NCT06077916
10/27.03.2023
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • acute upper GI bleeding (<12 hours)

Exclusion

Exclusion Criteria:

  • prokinetics <12 hours
  • allergy to azithromycin
  • use of contraindicated drugs (due to interactions)
  • pregnancy
  • physician option

Study Design

Total Participants: 223
Treatment Group(s): 2
Primary Treatment: Saline solution
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
November 01, 2024

Study 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.

Connect with a study center

  • Colentina Clinical Hospital

    Bucuresti, Bucharest 020125
    Romania

    Active - Recruiting

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