search
Back to results

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

Primary Purpose

Acute Lung Injury, Acute Kidney Injury, Hypercapnia

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
multiECCO2R blood-gas exchanger
Sponsored by
Fresenius Medical Care Deutschland GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring CO2 removal, Continuous Renal Replacement Therapy, blood-gas exchanger, CRRT, multiECCO2R

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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

Sites / Locations

  • Universitätsklinikum ErlangenRecruiting
  • Universitätsklinikum Regensburg Klinik und Poliklinik für Innere MedizinRecruiting
  • Klinikum DonaustaufRecruiting
  • Universitätsklinikum HamburgRecruiting
  • Klinikum HerfordRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment with the blood-gas exchanger multiECCO2R for CO2 removal

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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))

Full Information

First Posted
April 29, 2021
Last Updated
July 30, 2023
Sponsor
Fresenius Medical Care Deutschland GmbH
Collaborators
CERES GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT04871893
Brief Title
Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Medical Care Deutschland GmbH
Collaborators
CERES GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Acute Kidney Injury, Hypercapnia, Covid19
Keywords
CO2 removal, Continuous Renal Replacement Therapy, blood-gas exchanger, CRRT, multiECCO2R

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, non-comparative, multi-centre, open-label, interventional PMCF study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with the blood-gas exchanger multiECCO2R for CO2 removal
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
multiECCO2R blood-gas exchanger
Intervention Description
Treatment with the blood-gas exchanger multiECCO2R for CO2 removal
Primary Outcome Measure Information:
Title
Clinical efficiency variables: Change of PaCO2
Description
Change of PaCO2 during the first 30 minutes of treatment (Blood-gas analysis (BGA))
Time Frame
30 minutes after start of treatment
Secondary Outcome Measure Information:
Title
Technical efficiency variables: Change of pCO2
Description
Change of pCO2 within the extracorporeal circuit by pre- and post- CO2-exchanger during the treatment (Blood-gas analysis (BGA))
Time Frame
72 hours after start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuela Stauss-Grabo, Dr.
Phone
+49 6172 608 5248
Email
Manuela.Stauss-Grabo@fmc-ag.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Wammi
Phone
+49 6172 609 7634
Email
anna.wammi@fmc-ag.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Müller, Prof. Dr.
Organizational Affiliation
Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Matthias Lubnow, Dr. med.
Organizational Affiliation
Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carsten Willam, Dr
Phone
+49 9131 85 39240
Email
Carsten.willam@uk-erlangen.de
Facility Name
Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Lubnov, Dr.
Phone
+49 941 944 17356
Email
Matthias.Lubnow@klinik.uni-regensburg.de
Facility Name
Klinikum Donaustauf
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Blaas, Dr.
Email
Studienzentrum@klinikum-donaustauf.de
Facility Name
Universitätsklinikum Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Kluge, Prof.Dr.
Email
s.kluge@uke.de
Facility Name
Klinikum Herford
City
Herford
ZIP/Postal Code
32049
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Kähler, Prof. Dr.
Email
jan.kaehler@klinikum-herford.de

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs