Informations générales (source: ClinicalTrials.gov)

NCT05750576 Complet
Impact of ECMO Cannula Chlorhexidine-impregnated Dressings to Decrease Extracorporeal Membrane Oxygenation-cannula Related Infection Rate (DRESSING-ECMO)
Interventional
  • Maladies transmissibles
  • Syndrome de détresse respiratoire du nouveau-né
  • Choc cardiogénique
  • Lésion pulmonaire aigüe
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2023
décembre 2025
05 mai 2025
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
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FOCH Guillaume TACHON Complet 05/05/2025 07:12:13  Contacter

Critères

Tous
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)



- 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