Correction by ECCO2-R of Hypercapnia in Patients With DVP in Moderate to Severe ARDS Under Protective Ventilation. (COVAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03303807|
Recruitment Status : Completed
First Posted : October 6, 2017
Last Update Posted : July 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome Hypercapnia||Device: Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)||Not Applicable|
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.
The Secondary endpoints are:
- Relative change of capnia to H6 and H24 in relation to H0; proportion of patients with a decrease of at least 20% of PaCO2 to H6 and H24; changes in echocardiographic indices; hemodynamic parameters; alveolar deadspace and respiratory mechanics to H2, H6 and H24, compared to H0; Complications, Mortality at reanimation discharge (or on D28 if this date occurs before discharge of reanimation).
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 (Baxter): Single-use EC-marked extracorporeal circuit intended for use for at least 24 hours (maximum 72 hours).
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.
- The Prismaflex HP-X Set (Baxter): blood line set for extracorporeal blood circulation, EC marked or the HF 1400® set (Baxter) (for extra-corporeal CO2 purification combined with purification).
- The Prismaflex® monitor (Baxter), EC marked, is used routinely in intensive care (continuous extra-renal purification, therapeutic plasma exchange, haemoperfusion, hemopurification).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Carbon Dioxide Removal to Alleviate Right Ventricule Dysfunction During Acute Respiratory Distress Syndrome|
|Actual Study Start Date :||January 10, 2018|
|Actual Primary Completion Date :||February 25, 2019|
|Actual Study Completion Date :||March 21, 2019|
Extracorporeal CO2 removal
Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)
Device: Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)
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.
- Percentage of patients with corrected hypercapnia [ Time Frame: at hour 2 (H2) ]20% decrease in PaCO2 two hours after ECCO2-R initiation
- Relative change of capnia at H6 and H24 after ECCO2-R [ Time Frame: at hour 6 (H6), at hour 24 (H24) ]
- Proportion of patients with a decrease of at least 20% of PaCO2 to H6 and H24 [ Time Frame: H6, H24 ]
- Changes in echocardiographic indices [ Time Frame: H2, H6, H24 ]Changes in echocardiographic indices at H2, H6 and H24
- Changes in hemodynamic parameters [ Time Frame: H2, H6, H24 ]Changes in hemodynamic parameters at H2, H6 and H24
- Changes in alveolar deadspace [ Time Frame: H2, H6, H24 ]Changes in alveolar deadspace at H2, H6 and H24
- Changes in respiratory mechanics [ Time Frame: H2, H6, H24 ]Changes in respiratory mechanics at H2, H6 and H24
- Number of complications related to ECCO2-R technique [ Time Frame: ICU Discharge or day 28 ]
- Percentage of mortality [ Time Frame: ICU discharge or day 28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303807
|Henri Mondor Hospital|
|Creteil, France, 94000|
|Study Chair:||Armand Mekontso Dessap, MD, PhD||Assistance Publique - Hôpitaux de Paris|