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

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)

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.

Inclusion Criteria:

• Informed consent signed and dated by the investigator; and:

  1. if patient is able to give consent: by the study patient
  2. if patient is unable to give consent: by the legal representative or
  3. 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