Status:
COMPLETED
Correction by ECCO2-R of Hypercapnia in Patients With DVP in Moderate to Severe ARDS Under Protective Ventilation.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Respiratory Distress Syndrome
Hypercapnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pulmonary vascular dysfunction (DVP) is associated with a pejorative prognosis during ARDS. There is no specific therapeutic intervention to thwart it. Extracorporeal CO2 purification (ECCO2-R) is a t...
Detailed Description
This is a prospective, non-comparative, open-label, multicenter regional study, without random drawing or blindfolding. The primary objective of the study is the correction by ECCO2-R of hypercapnia ...
Eligibility Criteria
Inclusion
- Moderate to severe ARDS according to the Berlin definition;
- Pulmonary vascular dysfunction at echocardiography (pulmonary arterial hypertension, right ventricular dilatation or dyskinesia of the interventricular septum);
- Refractory hypercapnia, defined by a PaCO2 ≥48 mmHg in spite of the reduction of the instrumental dead space and the increase of the respiratory rate.
- Free and informed written consent for persons in a position to consent; consent of the support person/parent/relative in case of incapacity to consent; inclusion in emergency situations (Article L1122-1-2 of the CSP)
Exclusion
- Age \<18 years;
- Known pregnancy or breastfeeding;
- Contra-indication to curative anticoagulation, thrombocytopenia \<50 G / L, heparin-induced thrombocytopenia, known hypersensitivity to heparin or to compounds;
- Femoral or jugular venous access impossible;
- Refractory hypoxemia with indication at ECMO;
- No affiliation to social security or beneficiary
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03303807
Start Date
January 10 2018
End Date
March 21 2019
Last Update
July 5 2019
Active Locations (1)
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1
Henri Mondor Hospital
Créteil, France, 94000