Clinical trial NCT02606240: Low-Flow CO2 Removal for Mild to Moderate ARDS With PRISMALUNG
Official title: Extracorporeal CO2 Removal (ECCO2R) With a Renal Replacement Platform (PRISMALUNG) to Enhance Lung Protective Ventilation in Patients With Mild to Moderate Acute Respiratory Distress Syndrome (ARDS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire, Amiens
name: Centre Hospitalier Universitaire de Besancon
name: University Hospital, Clermont-Ferrand
name: University Hospital, Montpellier
First posted: 2015-11-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mild to Moderate ARDS according to the Berlin definition of ARDS

Brief summary: This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.

Detailed description: Extracorporeal CO2 removal (ECCO2R) with a low-flow CO2 removal device (Prismalung, Gambro-Baxter) integrated on the Prismaflex platform (Gambro-Baxter) allows tidal volume (Vt) and plateau pressure reduction in patients with mild to moderate ARDS. This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of ECCO2R following Vt and plateau pressure reduction in patients with mild to moderate ARDS. Safety variables during treatment will also be analyzed. A series of 20 consecutive patients will be included in this observational study.

Eligibility criteria: Inclusion Criteria:

* Mechanical ventilation with expected duration of \>24 hours
* Mild to moderate Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: 100 mmHg \<PaO2/FiO2 \<300 mmHg, with PEEP \> 5 cmH2O

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Severe hypoxemia with PaO2/FiO2 \<100 mmHg
* Body mass index \> 40 kg/m2
* Decompensated heart insufficiency or acute coronary syndrome
* Severe Chronic obstructive pulmonary disease (COPD)
* Major respiratory acidosis with PaCO2 \>60 mmHg
* Acute brain injury
* Severe liver insufficiency (Child-Pugh scores \>7) or fulminant hepatic failure
* Heparin-induced thrombocytopenia
* Contraindication for systemic anticoagulation
* Patient moribund, decision to limit therapeutic interventions
* Catheter access to femoral vein or jugular vein impossible
* Pneumothorax
* Platelet \<50 G/L
* Lacking consent

Primary outcomes:
measure: Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.
timeFrame: 24 hours
Secondary outcomes:
measure: Assessment of changes in Vt
timeFrame: 24 hours
measure: Assessment of changes in Plateau Pressure
timeFrame: 24 hours
measure: Assessment of changes in respiratory rate
timeFrame: 24 hours
measure: Assessment of changes in Positive End-Expiratory Pressure, PEEP
timeFrame: 24 hours
measure: Change in vasopressor use
timeFrame: 24 hours
measure: Evaluation of lung recruitment/derecruitment
timeFrame: 24 hours
measure: Lifetime of the extracorporeal circulation
timeFrame: 7 days
measure: Number of participants with adverse events directly related to ECCO2R
timeFrame: 7 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU AMIENS, Département Anesthésie Réanimation
city: Besançon
country: France
facility: CHU Besançon, Réanimation
city: Clermont Ferrand
country: France
facility: CHU CLERMONT FERRAND, Département Anesthésie Réanimation
city: Montpellier
country: France
facility: CHU MONTPELLIER, Département Anesthésie Réanimation
city: Paris
country: France
facility: Hopital Pitié Salpetriere, Reanimation Medicale
Study officials:
References:
citation: Schmidt M, Jaber S, Zogheib E, Godet T, Capellier G, Combes A. Feasibility and safety of low-flow extracorporeal CO2 removal managed with a renal replacement platform to enhance lung-protective ventilation of patients with mild-to-moderate ARDS. Crit Care. 2018 May 10;22(1):122. doi: 10.1186/s13054-018-2038-5.