ARDSNCT03200314
Blood Recirculation and vvECMO
An observational study of ARDS and Extracorporeal Membrane Oxygenation, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
A prospective, observational study will be performed measuring recirculation of blood through a veno-venous Extracoporeal Membrane Oxygenation (vvECMO) in patients with acute respiratory distress syndrome (ARDS) on vvECMO. ECMO blood flow will be adjusted with respect to recirculation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Extracorporeal Membrane Oxygenation
- What is being tested?
- Measurment of blood recirculation
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 13 Aug 2017to 9 Aug 2018
- Phase
- Observational
- 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
Study population: Patients aged 18 years or older requiring veno-venous ECMO for treatment of refractory hypomxemia in ARDS.
Who may be able to join
- patients aged 18 years or older
- ARDS
- veno-venous ECMO
Who cannot join
- age < 18 years
- hemodynamic instability during measurement of recirculation
- pregnancy
- inability to obtain patient's consent or consent of legal guardian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurment of Blood Recirculation and Adjustment of vvECMO Blood Flow During Veno-venous Extracoporeal Membrane Oxygenation
A prospective, observational study will be performed measuring recirculation of blood through a veno-venous Extracoporeal Membrane Oxygenation (vvECMO) in patients with acute respiratory distress syndrome (ARDS) on vvECMO. ECMO blood flow will be adjusted with respect to recirculation.
- Conditions
- ARDS, Extracorporeal Membrane Oxygenation
- Being tested
- Measurment of blood recirculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurment of blood recirculationOther
Ultrasound based measurments of blood recirculating through the vvECMO circuit.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recirculation of vvECMO blood flow
Amount of ECMO blood flow recirculating through the vvECMO circuit
Measured: Once within first week after ICU admission during 4 hours
Secondary outcomes (2)
Reduction of vvECMO blood flow
Reduction of vvECMO blood flow if a significant recirculation can be measured
Measured: Once within first week after ICU admission during 4 hours
Arterial blood oxygen content after reduction of vvECMO blood flow
Change in arterial blood oygen content after reduction of vvECMO blood flow
Measured: Once within first week after ICU admission during 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start13 Aug 2017
- Primary completion9 Aug 2018
- Study completion9 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steffen Weber-Carstens, Charite University, Berlin, Germany
- Investigators
- Martin Russ, Dr. med., Principal investigator, Charite University Hospital BerlinPhilipp A Pickerodt, Dr. med., Principal investigator, Charite University Hospital BerlinSteffen Weber-Carstens, PD Dr. med., Principal investigator, Charite University Hospital Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200314
- Sponsor's protocol ID
- EA208317
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2017
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Behnel N, Heilmann W, Skrypnikov V, Weiss B, Seesko L, Pickerodt PA, Russ M. The Role of Recirculation-Guided Blood Flow Adjustment in Venovenous Extracorporeal Membrane Oxygenation: A Pilot Study. ASAIO J. 2026 Nov 1;72(11):953-959. doi: 10.1097/MAT.0000000000002796. Epub 2026 Jul 23.
PubMed 42490650
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurment of Blood Recirculation and Adjustment of vvECMO Blood Flow During Veno-venous Extracoporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT03200314
- Acronym / sponsor ID
- EA208317
- Conditions
- ARDS, Extracorporeal Membrane Oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 13 Aug 2017 (actual)
- Primary completion
- 9 Aug 2018 (actual)
- Study completion
- 9 Aug 2018 (actual)
- First posted
- 27 Jun 2017 (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.
A prospective, observational study will be performed measuring recirculation of blood through a veno-venous Extracoporeal Membrane Oxygenation (vvECMO) in patients with acute respiratory distress syndrome (ARDS) on vvECMO. ECMO blood flow will be adjusted with respect to recirculation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older requiring veno-venous ECMO for treatment of refractory hypomxemia in ARDS.
Key inclusion criteria (3 listed)
- patients aged 18 years or older
- ARDS
- veno-venous ECMO
Key exclusion criteria (4 listed)
- age < 18 years
- hemodynamic instability during measurement of recirculation
- pregnancy
- inability to obtain patient's consent or consent of legal guardian
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 |
|---|---|---|
| Measurment of blood recirculationUltrasound based measurments of blood recirculating through the vvECMO circuit. | Other | – |
Primary outcome
Recirculation of vvECMO blood flow
Time frame: Once within first week after ICU admission during 4 hours
Amount of ECMO blood flow recirculating through the vvECMO circuit
2 secondary outcomes
Reduction of vvECMO blood flow
Time frame: Once within first week after ICU admission during 4 hours
Arterial blood oxygen content after reduction of vvECMO blood flow
Time frame: Once within first week after ICU admission during 4 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 26 Jun 2020.
- Derived from this study: PubMed 42490650Behnel N, Heilmann W, Skrypnikov V, Weiss B, Seesko L, Pickerodt PA, Russ M. The Role of Recirculation-Guided Blood Flow Adjustment in Venovenous Extracorporeal Membrane Oxygenation: A Pilot Study. ASAIO J. 2026 Nov 1;72(11):953-959. doi: 10.1097/MAT.0000000000002796. Epub 2026 Jul 23.
- Individual participant dataSharing planned: No
Related trials for ARDS
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruitingPhase 2
Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults
Acute Respiratory Distress Syndrome, ARDS
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingObservational study
Pulmonary Immune Cell-microbiome Interactions in ARDS
ARDS, Human
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.
Martin Russ, Dr. med. principal investigator
Charite University Hospital Berlin
Philipp A Pickerodt, Dr. med. principal investigator
Charite University Hospital Berlin
Steffen Weber-Carstens, PD Dr. med. principal investigator
Charite University Hospital Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS and Extracorporeal Membrane Oxygenation, run by Charite University, Berlin, Germany 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 3 inclusion and 4 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 26 Jun 2020. 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?
Recirculation of vvECMO blood flow (time frame: Once within first week after ICU admission during 4 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 NCT03200314, which also lists 1 linked publication.
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 26 Jun 2020.