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

Assistance Publique - Hôpitaux de Paris

Status: Completed

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

Treatments: Device: Chlorhexidine-impregnated dressings; Device: Non impregnated dressings

Study type: Interventional

Funder types: Other

Identifiers

NCT05750576

2020-A02557-32 (Other Identifier)

APHP190190

Details and patient eligibility

About

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

Full 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.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups, including a placebo group

Chlorhexidine-impregnated dressings

Experimental group

Treatment:

Device: Chlorhexidine-impregnated dressings

Non impregnated dressings

Placebo Comparator group

Treatment:

Device: Non impregnated dressings