ARDSNCT04351906
Low-flow Extracorporeal Carbon Dioxide Removal in COVID-19-associated Acute Respiratory Distress Syndrome
A study testing ECCO2R in people with ARDS and Hypercapnic Respiratory Failure, run by University of Giessen at 1 site in Germany.
Trial summary
The study aims to investigate the efficacy of extracorporeal CO2 removal for correction of hypercapnia in coronavirus disease 19 (COVID-19)-associated acute respiratory distress syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Hypercapnic Respiratory Failure, AKI
- What is being tested?
- ECCO2R
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 3 May 2020to 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
- mild-to-moderate ARDS according to the Berlin definition
- lung-protective ventilation with positive end-expiratory pressure (PEEP) > 5 cm of water on mechanical ventilation expected to last > 24 h
- hypercapnia <80 mmHg
- bilateral opacities on chest imaging
Who cannot join
- age < 18 years
- pregnancy
- patients with decompensated heart failure or acute coronary syndrome
- respiratory acidosis with persistent partial pressure of blood carbon dioxide (PCO2) levels >80 mmHg
- acute brain injury
- severe liver insufficiency (Child-Pugh scores > 7) or fulminant hepatic failure
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- decision to limit therapeutic interventions
- catheter access to femoral vein or jugular vein impossible
- pneumothorax
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Giessen and Marburg, Giessen
Giessen, Hesse, 35382
About this study
Official title: Low-flow Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform for Correction of Hypercapnia in COVID-19-associated Acute Respiratory Distress Syndrome
The study aims to investigate the efficacy of extracorporeal CO2 removal for correction of hypercapnia in coronavirus disease 19 (COVID-19)-associated acute respiratory distress syndrome
Read the detailed description
The prevalence of acute respiratory distress syndrome (ARDS) caused by COVID-19 is approximately 8%. Lung-protective ventilation is the current standard of care for ARDS. It limits lung and distal organ impairment, but is associated with hypercapnia in approximately 14% of patients with mild to moderate ARDS and almost all patients with severe ARDS. In this setting, early implementing of an extracorporeal CO2 removal (ECCO2R) therapy may prevent further escalation of invasiveness of therapy (eg, need for extracorporeal membrane oxygenation (ECMO)). A number of low-flow ECCO2R devices are now available and some of those can be integrated into a renal replacement therapy (RRT) platform. This study aims to investigate the efficacy of an original ECCO2R system used in conjunction with a RRT platform in hypercapnic patients with COVID-19-associated mild-to-moderate ARDS with or without acute kidney injury (AKI) necessitating RRT.
- Conditions
- ARDS, Hypercapnic Respiratory Failure, AKI
- Being tested
- ECCO2R
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECCO2RDevice
ECCO2R integrated into the multiFiltrate device
| Study group | Role | What they receive |
|---|---|---|
| ECCO2R | Other | ECCO2R in patients with mild to moderate ARDS with/without AKI requiring dialysis. Receives: Device: ECCO2R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment
Delta partial pressure of carbon dioxide change during ECCO2R treatment
Measured: Up to 72 hours
Secondary outcomes (7)
Change in vasopressor use during ECCO2R
Epinephrine and norepinephrine dose, mcg/kg/min
Measured: Up to 72 hours
Assessment of changes in tidal volume during ECCO2R
Assessment of changes in tidal volume
Measured: Up to 72 hours
Assessment of changes in pH during ECCO2R
Assessment of changes in pH
Measured: Up to 72 hours
Assessment of changes in Positive End-Expiratory Pressure during ECCO2R
Assessment of changes in Positive End-Expiratory Pressure
Measured: Up to 72 hours
Number of participants with adverse events directly related to ECCO2R
Adverse events directly related to ECCO2R are infection at the catheter site, hemorrhage at the cannulation site, air entry in the circuit.
Measured: Up to 72 hours
Rate of technical adverse events related to ECCO2R
Adverse events directly related to ECCO2R are clotting of the circuit.
Measured: Up to 72 hours
Delta change in venous partial pressure of carbon dioxide before and after ECCO2R membrane
Delta change in delta venous partial pressure of carbon dioxide before and after ECCO2R membrane
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start3 May 2020
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies 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
- ECCO2R
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Werner Seeger, MD, Study director, University Hospital Giessen and Marburg, Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351906
- Sponsor's protocol ID
- AZ 63/20
- Status last verified
- Mar 2025
- First submitted
- 9 Apr 2020
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schmidt M, Jaber S, Zogheib E, Godet T, Capellier G, Combes A. Feasibility and safety of low-flow extracorporeal CO2 removal managed with a renal replacement platform to enhance lung-protective ventilation of patients with mild-to-moderate ARDS. Crit Care. 2018 May 10;22(1):122. doi: 10.1186/s13054-018-2038-5.
PubMed 29743094Husain-Syed F, Birk HW, Wilhelm J, Ronco C, Ranieri VM, Karle B, Kuhnert S, Tello K, Hecker M, Morty RE, Herold S, Kehl O, Walmrath HD, Seeger W, Vadasz I. Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform to Enhance Lung-Protective Ventilation in Hypercapnic Patients With Coronavirus Disease 2019-Associated Acute Respiratory Distress Syndrome. Front Med (Lausanne). 2020 Nov 12;7:598379. doi: 10.3389/fmed.2020.598379. eCollection 2020.
PubMed 33304914
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-flow Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform for Correction of Hypercapnia in COVID-19-associated Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT04351906
- Acronym / sponsor ID
- AZ 63/20
- Conditions
- ARDS, Hypercapnic Respiratory Failure, AKI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 3 May 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Apr 2020 (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.
The study aims to investigate the efficacy of extracorporeal CO2 removal for correction of hypercapnia in coronavirus disease 19 (COVID-19)-associated acute respiratory distress syndrome
Detailed description
The prevalence of acute respiratory distress syndrome (ARDS) caused by COVID-19 is approximately 8%. Lung-protective ventilation is the current standard of care for ARDS. It limits lung and distal organ impairment, but is associated with hypercapnia in approximately 14% of patients with mild to moderate ARDS and almost all patients with severe ARDS. In this setting, early implementing of an extracorporeal CO2 removal (ECCO2R) therapy may prevent further escalation of invasiveness of therapy (eg, need for extracorporeal membrane oxygenation (ECMO)). A number of low-flow ECCO2R devices are now available and some of those can be integrated into a renal replacement therapy (RRT) platform. This study aims to investigate the efficacy of an original ECCO2R system used in conjunction with a RRT platform in hypercapnic patients with COVID-19-associated mild-to-moderate ARDS with or without acute kidney injury (AKI) necessitating RRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ECCO2R
| Arm | Type | Receives |
|---|---|---|
| ECCO2R | Other | Device: ECCO2RECCO2R in patients with mild to moderate ARDS with/without AKI requiring dialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- mild-to-moderate ARDS according to the Berlin definition
- lung-protective ventilation with positive end-expiratory pressure (PEEP) > 5 cm of water on mechanical ventilation expected to last > 24 h
- hypercapnia <80 mmHg
- bilateral opacities on chest imaging
Key exclusion criteria (9 listed)
- age < 18 years
- pregnancy
- patients with decompensated heart failure or acute coronary syndrome
- respiratory acidosis with persistent partial pressure of blood carbon dioxide (PCO2) levels >80 mmHg
- acute brain injury
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 |
|---|---|---|
| ECCO2RECCO2R integrated into the multiFiltrate device | Device | ECCO2R |
Primary outcome
Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment
Time frame: Up to 72 hours
Delta partial pressure of carbon dioxide change during ECCO2R treatment
7 secondary outcomes
Change in vasopressor use during ECCO2R
Time frame: Up to 72 hours
Assessment of changes in tidal volume during ECCO2R
Time frame: Up to 72 hours
Assessment of changes in pH during ECCO2R
Time frame: Up to 72 hours
Assessment of changes in Positive End-Expiratory Pressure during ECCO2R
Time frame: Up to 72 hours
Number of participants with adverse events directly related to ECCO2R
Time frame: Up to 72 hours
Rate of technical adverse events related to ECCO2R
Time frame: Up to 72 hours
Delta change in venous partial pressure of carbon dioxide before and after ECCO2R membrane
Time frame: Up to 72 hours
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 4 Mar 2025.
- Results publication: PubMed 29743094Schmidt M, Jaber S, Zogheib E, Godet T, Capellier G, Combes A. Feasibility and safety of low-flow extracorporeal CO2 removal managed with a renal replacement platform to enhance lung-protective ventilation of patients with mild-to-moderate ARDS. Crit Care. 2018 May 10;22(1):122. doi: 10.1186/s13054-018-2038-5.
- Derived from this study: PubMed 33304914Husain-Syed F, Birk HW, Wilhelm J, Ronco C, Ranieri VM, Karle B, Kuhnert S, Tello K, Hecker M, Morty RE, Herold S, Kehl O, Walmrath HD, Seeger W, Vadasz I. Extracorporeal Carbon Dioxide Removal Using a Renal Replacement Therapy Platform to Enhance Lung-Protective Ventilation in Hypercapnic Patients With Coronavirus Disease 2019-Associated Acute Respiratory Distress Syndrome. Front Med (Lausanne). 2020 Nov 12;7:598379. doi: 10.3389/fmed.2020.598379. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
Werner Seeger, MD study director
University Hospital Giessen and Marburg, Giessen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECCO2R in people with ARDS and Hypercapnic Respiratory Failure, run by University of Giessen at 1 site 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 4 inclusion and 9 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 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Delta change in arterial partial pressure of carbon dioxide during ECCO2R treatment (time frame: Up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04351906, which also lists 2 linked publications.
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 4 Mar 2025.