Cardiogenic ShockDRESSING-ECMONCT05750576
Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Oxygenation-cannula Related Infection Rate
A study testing Chlorhexidine-impregnated dressings and Non impregnated dressings in people with Cardiogenic Shock and Extracorporeal Membrane Oxygenation Complication, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication, Acute Respiratory Distress Syndrome
- What is being tested?
- Chlorhexidine-impregnated dressings and Non impregnated dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 6 sitesFrance
- Study dates
- 15 Jun 2023to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Besançon - Hôpital Jean Minjoz
Besançon, 25000
CH Sud Francilien
Corbeil-Essonnes, 91100
Hôpital Henri-Mondor
Créteil, 94000
CHRU Nancy - Hôpitaux de Brabois
Nancy, 54500
Hôpital Pitié Salpêtrière
Paris, 75013
Hôpital Foch
Suresnes, 92150
About this study
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
Read the 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.
- Conditions
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication, Acute Respiratory Distress Syndrome, Infections
- Being tested
- Chlorhexidine-impregnated dressings, Non impregnated dressings
- Keywords
- ECMO, Cardiogenic Shock, ARDS, Infection
- Medical subject headings
- Shock, Cardiogenic, Respiratory Distress Syndrome, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine-impregnated dressingsDevice
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 dressingsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine-impregnated dressings | Experimental | Not described Receives: Device: Chlorhexidine-impregnated dressings |
| Non impregnated dressings | Placebo comparator | Not described Receives: Device: Non impregnated dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence per 1000 ECMO days of ECMO cannula-related infection episodes, associated or not with bacteremia/fungemia
Measured: From ECMO initiation date (baseline) and up to day 60
Secondary outcomes (9)
Colonization of ECMO cannulas at Day 7 and weaning from ECMO
Measured: Day 7 to 2 days after ECMO weaning date
Number of dressing changes for soiling or detachment
Measured: From day 1 to 2 days after ECMO weaning date
Number of days alive without antibiotics/fungal agents on ECMO
Measured: Between day 1 and Day 60
Total duration of ECMO
Measured: Between ECMO initiation date (baseline) and ECMO weaning date
Number of day in ICU
Measured: Between day 1 and Day 60
Overall survival
Measured: Day7, Day 30, Day 60
Cumulative incidence of ECMO cannula-related bacteremia/fungemia
Measured: From ECMO initiation date (baseline) and up to day 60
Cumulative incidence of each cannula infection endpoint in both arms
Measured: From ECMO initiation date (baseline) and up to day 60
Incidence of contact dermatitis or skin allergy
Measured: From ECMO initiation date (baseline) and up to day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start15 Jun 2023
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750576
- Sponsor's protocol ID
- APHP190190
- Other IDs
- 2020-A02557-32
- Acronym
- DRESSING-ECMO
- Status last verified
- Nov 2025
- First submitted
- 19 Jan 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Oxygenation-cannula Related Infection Rate
- ClinicalTrials.gov ID
- NCT05750576
- Acronym / sponsor ID
- DRESSING-ECMO / APHP190190
- Conditions
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication, Acute Respiratory Distress Syndrome, Infections
- Keywords
- ECMO, Cardiogenic Shock, ARDS, Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine-impregnated dressings | Experimental | Device: Chlorhexidine-impregnated dressings |
| Non impregnated dressings | Placebo comparator | Device: Non impregnated dressings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine-impregnated dressingsSterile 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. | Device | Chlorhexidine-impregnated dressings |
| Non impregnated dressingsSingle 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. | Device | Non impregnated dressings |
Primary outcome
Cumulative incidence per 1000 ECMO days of ECMO cannula-related infection episodes, associated or not with bacteremia/fungemia
Time frame: From ECMO initiation date (baseline) and up to day 60
9 secondary outcomes
Colonization of ECMO cannulas at Day 7 and weaning from ECMO
Time frame: Day 7 to 2 days after ECMO weaning date
Number of dressing changes for soiling or detachment
Time frame: From day 1 to 2 days after ECMO weaning date
Number of days alive without antibiotics/fungal agents on ECMO
Time frame: Between day 1 and Day 60
Total duration of ECMO
Time frame: Between ECMO initiation date (baseline) and ECMO weaning date
Number of day in ICU
Time frame: Between day 1 and Day 60
Overall survival
Time frame: Day7, Day 30, Day 60
Cumulative incidence of ECMO cannula-related bacteremia/fungemia
Time frame: From ECMO initiation date (baseline) and up to day 60
Cumulative incidence of each cannula infection endpoint in both arms
Time frame: From ECMO initiation date (baseline) and up to day 60
Incidence of contact dermatitis or skin allergy
Time frame: From ECMO initiation date (baseline) and up to day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine-impregnated dressings and Non impregnated dressings in people with Cardiogenic Shock and Extracorporeal Membrane Oxygenation Complication, run by Assistance Publique - Hôpitaux de Paris at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence per 1000 ECMO days of ECMO cannula-related infection episodes, associated or not with bacteremia/fungemia (time frame: From ECMO initiation date (baseline) and up to day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.