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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infections, Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication, Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Device: Chlorhexidine-impregnated dressings
* Device: Non impregnated dressings


Participation Criteria
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Eligibility Criteria
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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) 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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine-impregnated dressings<br> | Device: Chlorhexidine-impregnated dressings<br>* Sterile adhesive transparent dressings impregnated with Chlorhexidine Gluconate gel applied to ECMO cannulae for up to 7 consecutive days for each dressing, in the absence of exudation or bleeding at the point of insertion and until explantation of the ECMO, sometimes requiring dressing changes.<br>|
| Placebo Comparator: Non impregnated dressings<br> | Device: Non impregnated dressings<br>* Single transparent adhesive dressings not impregnated with Chlorhexidine Gluconate applied to ECMO cannulae for up to 7 consecutive days for each dressing, in the absence of exudation or bleeding at the point of insertion and until explantation of the ECMO, sometimes requiring dressing changes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonization of ECMO cannulas at Day 7 and weaning from ECMO |  | Day 7 to 2 days after ECMO weaning date | 
| Number of dressing changes for soiling or detachment |  | From day 1 to 2 days after ECMO weaning date | 
| Number of days alive without antibiotics/fungal agents on ECMO |  | Between day 1 and Day 60 | 
| Total duration of ECMO |  | Between ECMO initiation date (baseline) and ECMO weaning date | 
| Number of day in ICU |  | Between day 1 and Day 60 | 
| Overall survival |  | Day7, Day 30, Day 60 | 
| Cumulative incidence of ECMO cannula-related bacteremia/fungemia |  | From ECMO initiation date (baseline) and up to day 60 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, ECMO, Cardiogenic Shock, Infection