Acute Respiratory Distress SyndromeCOVAPNCT03303807
Correction by ECCO2-R of Hypercapnia in Patients With DVP in Moderate to Severe ARDS Under Protective Ventilation.
A study testing Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter) in people with Acute Respiratory Distress Syndrome and Hypercapnia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Hypercapnia
- What is being tested?
- Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2018to 21 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Carbon Dioxide Removal to Alleviate Right Ventricule Dysfunction During Acute Respiratory Distress Syndrome
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.
Read the 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.
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.
- Conditions
- Acute Respiratory Distress Syndrome, Hypercapnia
- Being tested
- Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)
- Keywords
- Extracorporeal CO2 removal (ECCO2-R), ARDS
- Medical subject headings
- Respiratory Distress Syndrome, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal CO2 removal | Other | Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter) Receives: Device: Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with corrected hypercapnia
20% decrease in PaCO2 two hours after ECCO2-R initiation
Measured: at hour 2 (H2)
Secondary outcomes (8)
Relative change of capnia at H6 and H24 after ECCO2-R
Measured: at hour 6 (H6), at hour 24 (H24)
Proportion of patients with a decrease of at least 20% of PaCO2 to H6 and H24
Measured: H6, H24
Changes in echocardiographic indices
Changes in echocardiographic indices at H2, H6 and H24
Measured: H2, H6, H24
Changes in hemodynamic parameters
Changes in hemodynamic parameters at H2, H6 and H24
Measured: H2, H6, H24
Changes in alveolar deadspace
Changes in alveolar deadspace at H2, H6 and H24
Measured: H2, H6, H24
Changes in respiratory mechanics
Changes in respiratory mechanics at H2, H6 and H24
Measured: H2, H6, H24
Number of complications related to ECCO2-R technique
Measured: ICU Discharge or day 28
Percentage of mortality
Measured: ICU discharge or day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start10 Jan 2018
- Primary completion25 Feb 2019
- Study completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armand Mekontso Dessap, MD, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303807
- Sponsor's protocol ID
- P160701
- Other IDs
- 2016-A01689-42
- Acronym
- COVAP
- Status last verified
- Sep 2018
- First submitted
- 26 Sep 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mekontso Dessap A, Bagate F, Repesse X, Blayau C, Fartoukh M, Canoui-Poitrine F, de Prost N, Vieillard-Baron A. Low-flow ECCO2R conjoined with renal replacement therapy platform to manage pulmonary vascular dysfunction with refractory hypercapnia in ARDS. Heliyon. 2023 Dec 19;10(1):e23878. doi: 10.1016/j.heliyon.2023.e23878. eCollection 2024 Jan 15.
PubMed 38226285
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Carbon Dioxide Removal to Alleviate Right Ventricule Dysfunction During Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03303807
- Acronym / sponsor ID
- COVAP / P160701
- Conditions
- Acute Respiratory Distress Syndrome, Hypercapnia
- Keywords
- Extracorporeal CO2 removal (ECCO2-R), ARDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal CO2 removal | Other | Device: Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Extracorporeal CO2 removal |
Primary outcome
Percentage of patients with corrected hypercapnia
Time frame: at hour 2 (H2)
20% decrease in PaCO2 two hours after ECCO2-R initiation
8 secondary outcomes
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 hemodynamic parameters
Time frame: H2, H6, H24
Changes in alveolar deadspace
Time frame: H2, H6, H24
Changes in respiratory mechanics
Time frame: H2, H6, 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 38226285Mekontso Dessap A, Bagate F, Repesse X, Blayau C, Fartoukh M, Canoui-Poitrine F, de Prost N, Vieillard-Baron A. Low-flow ECCO2R conjoined with renal replacement therapy platform to manage pulmonary vascular dysfunction with refractory hypercapnia in ARDS. Heliyon. 2023 Dec 19;10(1):e23878. doi: 10.1016/j.heliyon.2023.e23878. eCollection 2024 Jan 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armand Mekontso Dessap, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter) in people with Acute Respiratory Distress Syndrome and Hypercapnia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with corrected hypercapnia (time frame: at hour 2 (H2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03303807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.