multiECCO2R: Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy

Sponsor

Fresenius Medical Care Deutschland GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04871893

Collaborator

CERES GmbH (Industry)

Enrollment

Locations

Arm

8.2

Anticipated Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lung Injury Acute Kidney Injury Hypercapnia Covid19	Device: multiECCO2R blood-gas exchanger	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, non-comparative, multi-centre, open-label, interventional PMCF studyProspective, non-comparative, multi-centre, open-label, interventional PMCF study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Mar 25, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Device: multiECCO2R blood-gas exchanger Treatment with the blood-gas exchanger multiECCO2R for CO2 removal

Arm

Intervention/Treatment

Other: 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.

Device: multiECCO2R blood-gas exchanger

Treatment with the blood-gas exchanger multiECCO2R for CO2 removal

Outcome Measures

Primary Outcome Measures

Clinical efficiency variables: Change of PaCO2 [30 minutes after start of treatment]
Change of PaCO2 during the first 30 minutes of treatment (Blood-gas analysis (BGA))

Secondary Outcome Measures

Technical efficiency variables: Change of pCO2 [72 hours after start of treatment]
Change of pCO2 within the extracorporeal circuit by pre- and post- CO2-exchanger during the treatment (Blood-gas analysis (BGA))

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 ventilation parameters: tidal volume = 6 ml/kg PBW, PEEP to be adjusted according to the FiO2 , driving pressure < 15 cmH2O, max. inspiratory pressure < 30 cmH2O or TV=5 mmHg 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
Cardiogenic shock
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 < 75000/nL
Liver cirrhosis CHILD Pugh Classification > A
BMI > 40 kg/m²
Decision to limit therapeutic interventions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Erlangen	Erlangen	Bayern	Germany	91054
2	Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin	Regensburg	Bayern	Germany	93053

Sponsors and Collaborators

Fresenius Medical Care Deutschland GmbH
CERES GmbH

Investigators

Study Director: Thomas Müller, Prof. Dr., Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin
Principal Investigator: Matthias Lubnow, Dr. med., Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin