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

Last updated: February 26, 2025
Sponsor: Fresenius Medical Care Deutschland GmbH
Overall Status: Completed

Phase

N/A

Condition

Kidney Failure

Lung Injury

Acute Respiratory Distress Syndrome (Ards)

Treatment

multiECCO2R blood-gas exchanger

Clinical Study ID

NCT04871893
CRRT-CVVHD/HDF-01-D
CIV-21-03-035951
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • In case of female patients: pregnancy or lactation period (if patient is ≥ 55 yearsold 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

Total Participants: 28
Treatment Group(s): 1
Primary Treatment: multiECCO2R blood-gas exchanger
Phase:
Study Start date:
March 25, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Universitätsklinikum Erlangen

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin

    Regensburg, Bayern 93053
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Klinikum Donaustauf

    Donaustauf, 93093
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg

    Hamburg, 20246
    Germany

    Site Not Available

  • Klinikum Herford

    Herford, 32049
    Germany

    Site Not Available

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