Informations générales (source: ClinicalTrials.gov)
Randomized Controlled Phase II Trial of Poractant Alfa (Curosurf®) by Fiberoptic Bronchoscopy-directed Endobronchial Administration in Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 Viral Pneumonia (Caards-1)
Interventional
Phase 2
Dr Christophe LENCLUD (Voir sur ClinicalTrials)
mai 2020
juillet 2021
29 juin 2024
Surfactant replacement therapy (SRT) improves oxygenation and survival in NRDS and some
infant ARDS. SRT was tried in adult ARDS with conflicting results. Research by Filoche
and Grotberg helped to understand the failure of previous clinical trials and yielded a
strong scientific rationale for SRT success, now allowing to design a new administration
protocol for SRT in adults, to be tested by this clinical trial in COVID-19 adult ARDS
patients.
Patients will be randomized to receive either a bronchial fibroscopy alone (with
aspiration of secretions) or a bronchial fibroscopy with administration of 3 mL/kg of a
solution of poractant alpha diluted to 16 mg/mL and distributed into each of the 5 lobar
bronchi.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH FRANCOIS QUESNAY MANTES | Christophe LENCLUD, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- At least 18 years
- Intensive care unit admission.
- Intubation and mechanical ventilation since less than 72h.
- Positive end-expiratory pressure ≥ 5 cmH2O.
- Acute respiratory distress syndrome following Berlin definition.
- COVID-19
- PaO2/FiO2 ratio < 150 mmHg during at least 3 hours despite PEP trial.
- Compliance of the respiratory system < 50 mL/cmH2O
- At least 18 years
- Intensive care unit admission.
- Intubation and mechanical ventilation since less than 72h.
- Positive end-expiratory pressure ≥ 5 cmH2O.
- Acute respiratory distress syndrome following Berlin definition.
- COVID-19
- PaO2/FiO2 ratio < 150 mmHg during at least 3 hours despite PEP trial.
- Compliance of the respiratory system < 50 mL/cmH2O
- Contraindication to prone position.
- Pregnancy.
- Weight < 40 kg
- height < 140 cm or height > 190 cm.
- Profuse bronchorrhea (at least 1 succion per hour during 3 hours).
- Other significant cause than ARDS to the respiratory failure.
- Decision to limit active therapies.
- No arterial line in place.
- Obesity with weight / height ratio > 1 kg / cm.
- Impossible to give neuromuscular blockers (e.g. drug unavailable owing to global
pandemia).
- Severe chronic respiratory failure with oxygen at home.
- Other severe acute or chronic organ faillure (eg severe liver cirrhosis, severe
chronic cardiac failure).
- History of pneumonectomy or pulmonary lobectomy.
- Patient scheduled for extracorporeal membrane oxygenation.
- Known hypersensibility to Curosurf.
- Contraindication to bronchial fibroscopy.
- Person under legal protection.