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

Not Applicable

Completed

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

• Registration Number: NCT04871893
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-04
• Study Start: 2022-03-25
• Primary Completion: 2024-12-06
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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))

Trial Locations

Locations (6)

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Bayern, Germany

Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin; 🇩🇪 Regensburg, Bayern, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Klinikum Donaustauf; 🇩🇪 Donaustauf, Germany

Universitätsklinikum Hamburg; 🇩🇪 Hamburg, Germany

Klinikum Herford; 🇩🇪 Herford, Germany