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

Covid19 Clinical Trial

— multiECCO2R  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04871893
• Other study ID #: CRRT-CVVHD/HDF-01-D
• Secondary ID: CIV-21-03-035951
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: Manuela Stauss-Grabo, Dr.
• Phone: +49 6172 608 5248
• Email: Manuela.Stauss-Grabo[@]fmc-ag.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Lung Injury
• COVID-19
• Covid19
• Hypercapnia
• Lung Injury
• Wounds and Injuries

Intervention

Device:
• multiECCO2R blood-gas exchanger
Treatment with the blood-gas exchanger multiECCO2R for CO2 removal

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Klinikum Donaustauf	Donaustauf
Germany	Universitätsklinikum Erlangen	Erlangen	Bayern
Germany	Universitätsklinikum Hamburg	Hamburg
Germany	Klinikum Herford	Herford
Germany	Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin	Regensburg	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH	CERES GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficiency variables: Change of PaCO2	Change of PaCO2 during the first 30 minutes of treatment (Blood-gas analysis (BGA))	30 minutes after start of treatment
Secondary	Technical efficiency variables: Change of pCO2	Change of pCO2 within the extracorporeal circuit by pre- and post- CO2-exchanger during the treatment (Blood-gas analysis (BGA))	72 hours after start of treatment