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CompletedNCT03303807COVAPUpdated Jul 5, 2019

Correction by ECCO2-R of Hypercapnia in Patients With DVP in Moderate to Severe ARDS Under Protective Ventilation.

An interventional study of Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter) in Acute Respiratory Distress Syndrome and Hypercapnia, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-05.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

  1. 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.

  2. 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).
  3. 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.

02

Conditions studied

  • Acute Respiratory Distress Syndrome
  • Hypercapnia

Keywords

  • Extracorporeal CO2 removal (ECCO2-R)
  • ARDS
03

In context

Respiratory Distress Syndrome

1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.

This study's enrollment of 8 is below the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Browse Assistance Publique - Hôpitaux de Paris studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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);
  • 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

Exclusion Criteria:

  • Age \<18 years;
  • Known pregnancy or breastfeeding;
  • to curative anticoagulation, thrombocytopenia \<50 G / L, heparin-induced thrombocytopenia, known to heparin or to compounds;
  • Femoral or jugular venous access impossible;
  • hypoxemia with indication at ECMO;
  • No affiliation to social security or beneficiary
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Other
    Extracorporeal CO2 removal

    Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)

    Device: Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)

Interventions

  • DeviceExtracorporeal 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.

06

What researchers measure

Primary outcomes

  1. Percentage of patients with corrected hypercapnia

    20% decrease in PaCO2 two hours after ECCO2-R initiation

    Time frame: at hour 2 (H2)

Secondary outcomes

  1. Relative change of capnia at H6 and H24 after ECCO2-R

    Time frame: at hour 6 (H6), at hour 24 (H24)

  2. Proportion of patients with a decrease of at least 20% of PaCO2 to H6 and H24

    Time frame: H6, H24

  3. Changes in echocardiographic indices

    Changes in echocardiographic indices at H2, H6 and H24

    Time frame: H2, H6, H24

  4. Changes in hemodynamic parameters

    Changes in hemodynamic parameters at H2, H6 and H24

    Time frame: H2, H6, H24

  5. Changes in alveolar deadspace

    Changes in alveolar deadspace at H2, H6 and H24

    Time frame: H2, H6, H24

  6. Changes in respiratory mechanics

    Changes in respiratory mechanics at H2, H6 and H24

    Time frame: H2, H6, H24

  7. Number of complications related to ECCO2-R technique

    Time frame: ICU Discharge or day 28

  8. Percentage of mortality

    Time frame: ICU discharge or day 28

07

Study locations

1 site
  • Henri Mondor Hospital
    Creteil, 94000, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Feb 2019, 13 months.

Of 263 non-industry interventional studies with no phase under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 13 months is below that.

Counting every sponsor, half of 270 studies reached it within 24 months; a quarter within 12 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2017
First posted
Oct 6, 2017
StartActual
Jan 10, 2018
Primary completionActual
Feb 25, 2019
CompletionActual
Mar 21, 2019
Last update
Jul 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03303807
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Oct 6, 2017
Start date
Jan 10, 2018
Primary completion
Feb 25, 2019
Completion
Mar 21, 2019
Last update
Jul 5, 2019

Study contacts

Armand Mekontso Dessap, MD, PhD
study chair · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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