Study of Carbon Dioxide Removal to Alleviate Right Ventricule Dysfunction During Acute Respiratory Distress Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Percentage of patients with corrected hypercapnia
Study Overview
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 technique that has been very rapidly diffused and adopted in intensive care since commercialization of the devices but, the formal clinical evaluation is insufficient. It could significantly improve the prognosis of patients with both DVP and refractory hypercapnia.
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 in patients with DVP in moderate to severe ARDS under protective ventilation.
The primary endpoint is the percentage of patients with hypercapnia correction (defined as a 20% decrease in PaCO2 at H2 of ECCO2-R initiation).
The secondary objectives are:
- Demonstrate that ECCO2-R allows in hypercapnic ARDS and DVP patients to correct hypercapnia with H6 and H24, improve DVP and hemodynamics, reduce alveolar dead space, improvement of respiratory mechanics
- Assess the tolerance of the evaluated technique.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Extracorporeal CO2 removal
Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)
Intervention: Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter) (Device)
Outcomes
Primary Outcomes
Percentage of patients with corrected hypercapnia
Time Frame: at hour 2 (H2)
20% decrease in PaCO2 two hours after ECCO2-R initiation
Secondary Outcomes
- Percentage of mortality(ICU discharge or day 28)
- Relative change of capnia at H6 and H24 after ECCO2-R(at hour 6 (H6), at hour 24 (H24))
- Changes in hemodynamic parameters(H2, H6, H24)
- Changes in alveolar deadspace(H2, H6, H24)
- Number of complications related to ECCO2-R technique(ICU Discharge or day 28)
- Proportion of patients with a decrease of at least 20% of PaCO2 to H6 and H24(H6, H24)
- Changes in respiratory mechanics(H2, H6, H24)
- Changes in echocardiographic indices(H2, H6, H24)