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NCT05750576
Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Oxygenation-cannula Related Infection Rate
Conditions: Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication, Acute Respiratory Distress Syndrome, Infections
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 270
Sponsor: Assistance Publique - Hôpitaux de Paris
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
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 hoursObtained 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 yearsInitiation of ECMO for more than 24 hoursSurgical (i.e.
non percutaneous) cannulationPatient moribund on day of randomization, SAPS II >90Known allergy to chlorhexidineAntibiotic prophylaxis at ECMO cannulation
Source: ClinicalTrials.gov (NCT05750576). StuddyBuddy aggregates publicly available trial information.