Status:
COMPLETED
Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy
Lead Sponsor:
Fresenius Medical Care Deutschland GmbH
Collaborating Sponsors:
CERES GmbH
Conditions:
Acute Lung Injury
Acute Kidney Injury
Eligibility:
All Genders
18+ years
Phase:
NA
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 duri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04871893
Start Date
March 25 2022
End Date
December 31 2024
Last Update
February 28 2025
Active Locations (6)
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1
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
2
Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin
Regensburg, Bavaria, Germany, 93053
3
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
4
Klinikum Donaustauf
Donaustauf, Germany, 93093