Safety and Efficacy Evaluation of CO2 Removal in Combination with Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy (multiECCO2R)

Fresenius Medical Care (FMC)

Status: Enrolling

Conditions: Hypercapnia; Acute Kidney Injury; Acute Lung Injury; Covid19

Treatments: Device: multiECCO2R blood-gas exchanger

Study type: Interventional

Funder types: Industry

Identifiers

NCT04871893

CRRT-CVVHD/HDF-01-D

CIV-21-03-035951 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Treatment with the blood-gas exchanger multiECCO2R for CO2 removal

Other group

Description:

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.

Treatment:

Device: multiECCO2R blood-gas exchanger