Status:
TERMINATED
Procollagen-3 Driven Corticosteroids for Persistent Acute Respiratory Distress Syndrome
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Persistent ARDS
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Unresolved ARDS is defined by the persistence of ARDS criteria at the end of the first week of evolution despite an appropriate treatment of the cause of ARDS. A persistent ARDS is associated with an ...
Eligibility Criteria
Inclusion
- Age \>= 18 years
- Continuous endotracheal ventilation
- Moderate - severe ARDS according to Berlin definition with PaO2/FiO2 ≤ 200 with PEEP \>= 5 cm H2O
- Date of ARDS onset : \>= day 5 and ≤ day 14 after the onset of ARDS criteria (regardless of ARDS severity)
- Procollagen III above 9 µg/L in a bronchoalveolar lavage performed by the attending physician between day 3 and day 13 after the onset of ARDS and realized within 5 days prior to randomization
Exclusion
- Known pregnancy or breast feeding
- Participation to another interventional trial within 30 days with mortality or ventilator free days as the main endpoint
- Clinical evidence of active untreated infection
- A known, undrained abscess
- Intravascular nidus of infection
- Disseminated fungal infection
Key Trial Info
Start Date :
December 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03371498
Start Date
December 27 2018
End Date
November 29 2023
Last Update
January 3 2024
Active Locations (1)
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1
Assistance Publique Hôpitaux de Marseille
Marseille, France, 13354