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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 28
- Locations
- 12
- Primary Endpoint
- Clinical efficiency variables: Change of PaCO2
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment with the blood-gas exchanger multiECCO2R for CO2 removal
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.
Intervention: multiECCO2R blood-gas exchanger (Device)
Outcomes
Primary Outcomes
Clinical efficiency variables: Change of PaCO2
Time Frame: 30 minutes after start of treatment
Change of PaCO2 during the first 30 minutes of treatment (Blood-gas analysis (BGA))
Secondary Outcomes
- Technical efficiency variables: Change of pCO2(72 hours after start of treatment)