Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Oxygenation-cannula Related Infection Rate

Not Applicable

Not yet recruiting

• Conditions: Extracorporeal Membrane Oxygenation Complication; Infections; Cardiogenic Shock; Acute Respiratory Distress Syndrome
• Interventions: Device: Non impregnated dressings; Device: Chlorhexidine-impregnated dressings

• Registration Number: NCT05750576
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The Dressing-ECMO trial is a prospective, open-label, multicenter, controlled trial randomizing patients who received percutaneous ECMO to cannula chlorhexidine-impregnated dressing vs standard dressing. The study goal is to determine if cannula chlorhexidine-impregnated dressings can reduce the number of cannula major-related infections with or without bloodstream infection

Detailed Description

Open-label, multicenter, randomized, controlled trial. This study will be conducted in patients with cardiogenic shock or acute respiratory distress syndrome receiving percutaneous ECMO for less than 24h. All consecutive eligible patients will be proposed to participate. They will be randomly allocated in a 1:1 ratio to conventional cannula dressing, or cannula chlorhexidine-impregnated dressing, using an online, central randomisation service, to ensure allocation concealment. Blocked randomization will be performed using random block size. Randomization will be stratified according to center and ECMO type (i.e veno venous or arteriovenous). In both groups, peripheral blood sample will be cultured daily from first day on ECMO to 48h after ECMO removal, death on ECO or ECMO day 30 whichever occurs first. In case of ECMO cannula infection suspicion, deep samples of the cannula will be cultured according to the usual procedure.

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2023-01-19
• Study Start: 2023-02
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-01
• Last Update Posted: 2023-03-01
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Patients with cardiogenic shock or refractory acute respiratory distress syndrome ECMO VA or VV ECMO for less than 24 hours.
• ECMO duration > 48 hours
• Obtained written informed consent from the trusted person or family member/relative. Depending on the emergency consent, randomization may take place and consent of the trusted person/relative/family will be obtained as soon as possible. The patient will be asked to give his/her consent for the continuation of the trial when hid/her condition will allow.
• Affiliation to a social security system (excluding state medical aid)

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Exclusion Criteria

• Age <18 years
• Initiation of ECMO for more than 24 hours
• Surgical (i.e. non percutaneous) cannulation
• Patient moribund on day of randomization, SAPS II >90
• Known allergy to chlorhexidine
• Antibiotic prophylaxis at ECMO cannulation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non impregnated dressings	Non impregnated dressings	-
Chlorhexidine-impregnated dressings	Chlorhexidine-impregnated dressings	-

Primary Outcome Measures

Name	Time	Method
Cumulative incidence per 1000 ECMO days of ECMO cannula-related infection episodes, associated or not with bacteremia/fungemia	From ECMO initiation date (baseline) and up to day 60

Secondary Outcome Measures

Name	Time	Method
Number of dressing changes for soiling or detachment	From day 1 to 2 days after ECMO weaning date
Colonization of ECMO cannulas at Day 7 and weaning from ECMO	Day 7 to 2 days after ECMO weaning date
Number of days alive without antibiotics/fungal agents on ECMO	Between day 1 and Day 60
Cumulative incidence of ECMO cannula-related bacteremia/fungemia	From ECMO initiation date (baseline) and up to day 60
Overall survival	Day7, Day 30, Day 60
Total duration of ECMO	Between ECMO initiation date (baseline) and ECMO weaning date
Cumulative incidence of each cannula infection endpoint in both arms	From ECMO initiation date (baseline) and up to day 60
Incidence of contact dermatitis or skin allergy	From ECMO initiation date (baseline) and up to day 60
Number of day in ICU	Between day 1 and Day 60