Clinical trial NCT05750576: Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Oxygenation-cannula Related Infection Rate
Official title: Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Oxygenation-cannula Related Infection Rate
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiogenic Shock
Extracorporeal Membrane Oxygenation Complication
Acute Respiratory Distress Syndrome
Infections
Keywords: ECMO
Cardiogenic Shock
ARDS
Infection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence per 1000 ECMO days of ECMO cannula-related infection episodes, associated or not with bacteremia/fungemia
timeFrame: From ECMO initiation date (baseline) and up to day 60
Secondary outcomes:
measure: Colonization of ECMO cannulas at Day 7 and weaning from ECMO
timeFrame: Day 7 to 2 days after ECMO weaning date
measure: Number of dressing changes for soiling or detachment
timeFrame: From day 1 to 2 days after ECMO weaning date
measure: Number of days alive without antibiotics/fungal agents on ECMO
timeFrame: Between day 1 and Day 60
measure: Total duration of ECMO
timeFrame: Between ECMO initiation date (baseline) and ECMO weaning date
measure: Number of day in ICU
timeFrame: Between day 1 and Day 60
measure: Overall survival
timeFrame: Day7, Day 30, Day 60
measure: Cumulative incidence of ECMO cannula-related bacteremia/fungemia
timeFrame: From ECMO initiation date (baseline) and up to day 60
measure: Cumulative incidence of each cannula infection endpoint in both arms
timeFrame: From ECMO initiation date (baseline) and up to day 60
measure: Incidence of contact dermatitis or skin allergy
timeFrame: From ECMO initiation date (baseline) and up to day 60
Other outcomes:
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