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

Acute Respiratory Distress Syndrome Clinical Trial

— DRESSING-ECMO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05750576
• Other study ID #: APHP190190
• Secondary ID: 2020-A02557-32
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Matthieu SCHMIDT, MD
• Phone: +33142162937
• Email: matthieu.schmidt[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Cardiogenic Shock
• Communicable Diseases
• Extracorporeal Membrane Oxygenation Complication
• Infections
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Shock, Cardiogenic

Intervention

Device:
• Chlorhexidine-impregnated dressings
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.
• Non impregnated dressings
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

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