Henri Mondor Hospital
Créteil, 94000, France
NCT Number: NCT03303807
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Créteil, 94000, France
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:
The Secondary endpoints are:
The intervention is based on the use of ECCO2-R (PrismaLung®, Prismaflex ® Baxter) in eligible patients. ECCO2-R will be initiated as soon as possible after inclusion, for a duration of at least 24 H (possibly prolonged up to 72 H at the decision of reanimator), by jugular or femoral vein-venous.
The size of the catheters, the machine settings, in particular the blood flow and sweep will be standardized according to the state of the art and the recommendations of the manufacturer
The ECO2R venous technique uses devices consisting of a monitor, an exchanger and a pump.
The PrismaLung® kit is intended for use with the Prismaflex® monitor with software version 8.10 or later and its support in conjunction with Prismaflex® single use treatment sets.
So that each center has a dedicated monitor for research, this device will be provided by the Baxter laboratory. The monitor will be equipped with a holder for the Prismalung kit marked CE.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A low-flow CO2 removal device (Prismalung®, Baxter) will be used with a conventional renal replacement therapy (RRT) platform (Prismaflex®, Baxter). In patients already treated with continuous RRT because of renal failure or metabolic acidosis, the HF 1400® (Baxter) set will be used to combine RRT and decarboxylation. Gas flow through the gas exchanger will be set up to 10 L/min, with an oxygen concentration from 0.21 to 1 and a blood flow of 200-400 mL/min. Patients will be ventilated with a target tidal volume of 6 ml/kg (predicted body weight) and a target plateau pressure below 30 cmH2O.
Time frame: at hour 2 (H2)
20% decrease in PaCO2 two hours after ECCO2-R initiation
Time frame: at hour 6 (H6), at hour 24 (H24)
Time frame: H6, H24
Time frame: H2, H6, H24
Changes in echocardiographic indices at H2, H6 and H24
Time frame: H2, H6, H24
Changes in hemodynamic parameters at H2, H6 and H24
Time frame: H2, H6, H24
Changes in alveolar deadspace at H2, H6 and H24
Time frame: H2, H6, H24
Changes in respiratory mechanics at H2, H6 and H24
Time frame: ICU Discharge or day 28
Time frame: ICU discharge or day 28
Assistance Publique - Hôpitaux de Paris
Other
Study of Carbon Dioxide Removal to Alleviate Right Ventricule Dysfunction During Acute Respiratory Distress Syndrome
Acronym: COVAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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