Acute Lung InjurymultiECCO2RNCT04871893
Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy
A study testing multiECCO2R blood-gas exchanger in people with Acute Lung Injury and Acute Kidney Injury, run by Fresenius Medical Care Deutschland GmbH at 6 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury, Acute Kidney Injury, Hypercapnia
- What is being tested?
- multiECCO2R blood-gas exchanger
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 6 sitesGermany
- Study dates
- 25 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Charité - Universitätsmedizin Berlin
Berlin, 10117
Klinikum Donaustauf
Donaustauf, 93093
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Universitätsklinikum Hamburg
Hamburg, 20246
Klinikum Herford
Herford, 32049
Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin
Regensburg, Bavaria, 93053
About this study
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)
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.
- Conditions
- Acute Lung Injury, Acute Kidney Injury, Hypercapnia, Covid19
- Being tested
- multiECCO2R blood-gas exchanger
- Keywords
- CO2 removal, Continuous Renal Replacement Therapy, blood-gas exchanger, CRRT, multiECCO2R
- Medical subject headings
- Acute Lung Injury, Acute Kidney Injury, Hypercapnia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiECCO2R blood-gas exchangerDevice
Treatment with the blood-gas exchanger multiECCO2R for CO2 removal
| Study group | Role | What they receive |
|---|---|---|
| Treatment with the blood-gas exchanger multiECCO2R for CO2 removal | Other | 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. Receives: Device: multiECCO2R blood-gas exchanger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficiency variables: Change of PaCO2
Change of PaCO2 during the first 30 minutes of treatment (Blood-gas analysis (BGA))
Measured: 30 minutes after start of treatment
Secondary outcomes (1)
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))
Measured: 72 hours after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start25 Mar 2022
- Primary completion6 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-comparative, multi-centre, open-label, interventional PMCF study
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CERES GmbH
- Responsible party
- Sponsor
- Investigators
- Thomas Müller, Prof. Dr., Study director, Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere MedizinMatthias Lubnow, Dr. med., Principal investigator, Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871893
- Sponsor's protocol ID
- CRRT-CVVHD/HDF-01-D
- Other IDs
- CIV-21-03-035951
- Acronym
- multiECCO2R
- Status last verified
- Feb 2025
- First submitted
- 29 Apr 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04871893
- Acronym / sponsor ID
- multiECCO2R / CRRT-CVVHD/HDF-01-D
- Conditions
- Acute Lung Injury, Acute Kidney Injury, Hypercapnia, Covid19
- Keywords
- CO2 removal, Continuous Renal Replacement Therapy, blood-gas exchanger, CRRT, multiECCO2R
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- CERES GmbH
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-comparative, multi-centre, open-label, interventional PMCF study
| Arm | Type | Receives |
|---|---|---|
| Treatment with the blood-gas exchanger multiECCO2R for CO2 removal | Other | Device: multiECCO2R blood-gas exchangerTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Informed consent signed and dated by the investigator; and:
- Minimum age of 18 years
- Body weight greater than 40 kg
- Acute Kidney Injury (AKI) with clinical indication for CRRT
- Hypercapnia with indication for ECCO2R:
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multiECCO2R blood-gas exchangerTreatment with the blood-gas exchanger multiECCO2R for CO2 removal | Device | Treatment with the blood-gas exchanger multiECCO2R for CO2 removal |
Primary outcome
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))
1 secondary outcome
Technical efficiency variables: Change of pCO2
Time frame: 72 hours after start of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Müller, Prof. Dr. study director
Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin
Matthias Lubnow, Dr. med. principal investigator
Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multiECCO2R blood-gas exchanger in people with Acute Lung Injury and Acute Kidney Injury, run by Fresenius Medical Care Deutschland GmbH at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficiency variables: Change of PaCO2 (time frame: 30 minutes after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.