Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy

Study Overview
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Brief Summary
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Objective of the study is to assess the safety and efficacy of CO2 removal by the multiECCO2R (CO2 Removal System) on the multiFiltrate/multiFiltrate Pro in veno-venous extracorporeal circulation during continuous renal replacement therapy (CRRT) in patients presenting with hypercapnia due to acute lung failure and acute kidney injury.

Official Title
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Safety and Effcacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy (A Clinical Study in Patients With Combined Renal Failure and Hypercapnia Due to Acute Lung Failure in COVID-19 and Other Forms of Respiratory Insufficiency)

Conditions
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Acute Lung Injury, Acute Kidney Injury, Hypercapnia, Covid19

Intervention / Treatment
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* Device: multiECCO2R blood-gas exchanger


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed and dated by the investigator; and: if patient is able to give consent: by the study patient if patient is unable to give consent: by the legal representative or if an emergency situation is determined: by an independent consultant physician Minimum age of 18 years Study-specific: Body weight greater than 40 kg Acute Kidney Injury (AKI) with clinical indication for CRRT Hypercapnia with indication for ECCO2R: (paCO2 ≥ 55 mmHg at given best possible protective ventilation parameters: Guiding parameters: tidal volume = 6 ml/kg PBW, PEEP to be adjusted according to the FiO2 1, driving pressure < 15 cmH2O, max. inspiratory pressure < 30 cmH2O or TV<=5 ml/kg when max. inspiratory pressure< 30 cmH2O cannot be held) Vascular access and Shaldon catheter allowing blood flow of 100 ml/min to 500 ml/min Arterial line in place, allowing blood sampling Estimated life expectancy greater than 3 days Exclusion Criteria: In case of female patients: pregnancy or lactation period (if patient is ≥ 55 years old or have been surgically sterilized, a negative pregnancy test is not required) Participation in an interventional clinical study during the preceding 72 hours Previous participation in the same study Study-specific Severe ARDS (Berlin definition): PaO2/FiO2 < 100 mmHg Intracerebral haemorrhage Intracranial hypertension Acute myocardial infarction Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT Type II), if heparin is used as anticoagulant severe liver insufficiency or fulminant hepatic failure Uncontrolled bleeding and coagulation disorders, thrombocytopenia < 75000µL Liver cirrhosis CHILD Pugh Classification > A BMI > 40 kg/m² Decision to limit therapeutic interventions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, non-comparative, multi-centre, open-label, interventional PMCF study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment with the blood-gas exchanger multiECCO2R for CO2 removal<br>Treatment of patients suffering from hypercapnia due to acute lung failure and acute kidney injury (AKI). Patients will be treated up to 72 hours with CVVHD/HDF with a standard multiFiltrate blood line kit (multiFiltrate or multiFiltrate Pro). In order to perform an ECCO2R procedure during CVVHD/HDF treatment, the blood-gas exchanger multiECCO2R is inserted in a specifically designed blood line kit downstream of the hemodialyzer. | Device: multiECCO2R blood-gas exchanger<br>* Treatment with the blood-gas exchanger multiECCO2R for CO2 removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficiency variables: Change of PaCO2 | Change of PaCO2 during the first 30 minutes of treatment (Blood-gas analysis (BGA)) | 30 minutes after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical efficiency variables: Change of pCO2 | Change of pCO2 within the extracorporeal circuit by pre- and post- CO2-exchanger during the treatment (Blood-gas analysis (BGA)) | 72 hours after start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CO2 removal, Continuous Renal Replacement Therapy, blood-gas exchanger, CRRT, multiECCO2R