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

February 22, 2024 updated by: Fresenius Medical Care Deutschland GmbH

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)

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Bayern
      • Erlangen, Bayern, Germany, 91054
      • Regensburg, Bayern, Germany, 93053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Treatment with the blood-gas exchanger multiECCO2R for CO2 removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical efficiency variables: Change of PaCO2
Time Frame: 30 minutes after start of treatment
Change of PaCO2 during the first 30 minutes of treatment (Blood-gas analysis (BGA))
30 minutes after start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical efficiency variables: Change of pCO2
Time Frame: 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))
72 hours after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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