Extracorporeal Membrane OxygenationNCT04754854
Reduction of Blood Recirculation in Veno-Venous ECMO
An observational study of Extracorporeal Membrane Oxygenation and Acute Respiratory Distress Syndrome, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Blood which recirculates through the circuit of a veno-venous Extracorporeal Membrane Oxygenation (V-V ECMO) does not contribute to the systemic oxygenation of a patient on V-V ECMO and is called the recirculation fraction (Rf). Theoretically, the optimization of ECMO blood flow is possible using Rf measurements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation, Acute Respiratory Distress Syndrome
- How many people
- 136 participants
- Where
- 1 siteGermany
- Study dates
- 20 Nov 2020to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Inclusion Criteria: * patients aged 18 years or older * ARDS * veno-venous ECMO Exclusion Criteria: * age < 18 years * hemodynamic instability during measurement of recirculation * pregnancy * inability to obtain patient's consent or consent of legal guardian
Patients aged 18 years or older requiring veno-venous ECMO for treatment of refractory hypoxemia in ARDS.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, 13353
Steffen Weber-Carstens, Prof. Dr. med., 0049-30450651055, steffen.webercarstens@charite.de
Martin Russ, Dr. med., 0049-30450651268, martin.russ@charite.de
About this study
Official title: Reduction of Blood Recirculation in Veno-Venous ECMO Through Ultrasound Dilution Measurements (ECMO Circulation Study)
Blood which recirculates through the circuit of a veno-venous Extracorporeal Membrane Oxygenation (V-V ECMO) does not contribute to the systemic oxygenation of a patient on V-V ECMO and is called the recirculation fraction (Rf). Theoretically, the optimization of ECMO blood flow is possible using Rf measurements.
A prospective, observational study will be performed measuring the Rf of total ECMO blood flow in patients with acute respiratory distress syndrome (ARDS) on V-V ECMO with an ultrasound dilution technique.
ECMO blood flow will be optimized by reducing ECMO blood flow in accordance with the measured Rf as long as systemic oxygenation is not compromised.
Read the detailed description
Based on data from the 'Blood Recirculation and vvECMO' trial (ClinicalTrials.gov ID: NCT03200314) (i.e. an expected frequency of successful blood flow reduction of 66.7%), using a one-sample Chi square test, a two-sided type-1 error of 5%, a power of 80%, a total of 68 patients is needed to show that the proportion of patients with a secure ECMO blood flow reduction is greater than 50%. Presumably, 136 Patients have to be included into the trial to study 68 patients with a relevant Rf since not all patients on V-V ECMO suffer from a high Rf.
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful ECMO blood flow reduction
Number of patients with a relevant recirculation fraction and successful ECMO blood flow reduction
Measured: Once within the first week after initiation of ECMO therapy
Secondary outcomes (22)
Recirculation fraction
Fraction of blood recirculating through the ECMO circuit
Measured: Once within the first week after initiation of ECMO therapy
Arterial blood oxygen content
Arterial blood oxygen content before vs. after reduction of ECMO blood flow
Measured: Once within the first week after initiation of ECMO therapy
Extracorporeal blood Flow
ECMO Blood Flow before vs. after reduction of ECMO blood flow
Measured: Once within the first week after initiation of ECMO therapy
Extracorporeal gas flow
ECMO Sweep Gas flow
Measured: Once within the first week after initiation of ECMO therapy
Length of ECMO therapy
Days on ECMO
Measured: Daily until the end of ECMO therapy (approximately 14 days)
Cannula position and distance
The distance between the tip of drainage and return cannula will be measured in the existing medical imaging (e.g. CT scans)
Measured: Once within the first week after initiation of ECMO therapy
Right heart dysfunction
Existing echocardiography will be evaluated for possible right heart dysfunction
Measured: Once within the first week after initiation of ECMO therapy
Length of mechanical ventilation
Length of mechanical ventilation
Measured: Entire duration of the ICU stay (approximately 28 days)
Complications of ECMO therapy
Incidence of cannula or system changes (i.e. due to circuit clotting), complications attributed to ECMO therapy like bleeding complications from the cannulation site, transfusion requirements, hemolysis
Measured: Length of ECMO therapy (approximately 14 days)
ICU mortality
ICU mortality
Measured: Entire duration of the ICU stay (approximately 28 days)
ICU length of stay
ICU length of stay
Measured: Entire duration of the ICU stay (approximately 28 days)
Incidence of ICU-acquired organ dysfunctions and complications
Cerebral-, cardiovascular-, cardiac- pulmonary-, gastrointestinal- and renal dysfunctions, ICU-acquired infections
Measured: Entire duration of the ICU stay (approximately 28 days)
ECMO blood flow over time
ECMO blood and sweep gas flow over time
Measured: Daily until the end of ECMO therapy (approximately 14 days)
ECMO sweep gas flow over time
ECMO sweep gas flow over time
Measured: Daily until the end of ECMO therapy (approximately 14 days)
Mobility at ICU discharge
Level of mobility the patient has reached at ICU discharge (recumbent, sitting, standing, walking with help, walking independently)
Measured: Discharge from the ICU (approximately 28 days)
Weaning level at ICU discharge
Level of weaning reached at ICU discharge
Measured: Discharge from the ICU (approximately 28 days)
Status of mechanical ventilation at ICU discharge
Status of mechanical ventilation at ICU discharge including all relevant settings and parameters
Measured: Discharge from the ICU (approximately 28 days)
Level of organ dysfunction at ICU discharge
Sepsis-related Organ Failure Assessment Score at ICU discharge
Measured: Discharge from the ICU (approximately 28 days)
Level of consciousness at ICU discharge
Glasgow Coma Scale at ICU discharge
Measured: Discharge from the ICU (approximately 28 days)
Level of disease severity
Acute Physiology And Chronic Health Evaluation at ICU discharge
Measured: Discharge from the ICU (approximately 28 days)
Hospital acquired infections related to ECMO therapy
Infection/colonisation of the ECMO circuit
Measured: Entire duration of ECMO therapy
Bleeding and thrombembolic complications of ECMO therapy
Bleeding complications, thrombembolic events, overall use of blood products and coagulation factors, electron microscopic evaluation of selected membranes after change or weaning of the ECMO circuit
Measured: Entire duration of ECMO therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start20 Nov 2020
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane OxygenationStudies 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
- 136 participants (estimated)
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 BerlinVladimir Skrypnikov, Dr. med., Principal investigator, Charite University Hospital BerlinSteffen Weber-Carstens, Prof. Dr. med., Principal investigator, Charite University Hospital Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754854
- Sponsor's protocol ID
- EA115620
- Status last verified
- Dec 2024
- First submitted
- 14 Sep 2020
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Blood Recirculation in Veno-Venous ECMO Through Ultrasound Dilution Measurements (ECMO Circulation Study)
- ClinicalTrials.gov ID
- NCT04754854
- Acronym / sponsor ID
- EA115620
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 15 Feb 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.
Blood which recirculates through the circuit of a veno-venous Extracorporeal Membrane Oxygenation (V-V ECMO) does not contribute to the systemic oxygenation of a patient on V-V ECMO and is called the recirculation fraction (Rf). Theoretically, the optimization of ECMO blood flow is possible using Rf measurements.
A prospective, observational study will be performed measuring the Rf of total ECMO blood flow in patients with acute respiratory distress syndrome (ARDS) on V-V ECMO with an ultrasound dilution technique.
ECMO blood flow will be optimized by reducing ECMO blood flow in accordance with the measured Rf as long as systemic oxygenation is not compromised.
Detailed description
Based on data from the 'Blood Recirculation and vvECMO' trial (ClinicalTrials.gov ID: NCT03200314) (i.e. an expected frequency of successful blood flow reduction of 66.7%), using a one-sample Chi square test, a two-sided type-1 error of 5%, a power of 80%, a total of 68 patients is needed to show that the proportion of patients with a secure ECMO blood flow reduction is greater than 50%. Presumably, 136 Patients have to be included into the trial to study 68 patients with a relevant Rf since not all patients on V-V ECMO suffer from a high Rf.
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
- Inclusion Criteria: * patients aged 18 years or older * ARDS * veno-venous ECMO Exclusion Criteria: * 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.
Primary outcome
Successful ECMO blood flow reduction
Time frame: Once within the first week after initiation of ECMO therapy
Number of patients with a relevant recirculation fraction and successful ECMO blood flow reduction
22 secondary outcomes
Recirculation fraction
Time frame: Once within the first week after initiation of ECMO therapy
Arterial blood oxygen content
Time frame: Once within the first week after initiation of ECMO therapy
Extracorporeal blood Flow
Time frame: Once within the first week after initiation of ECMO therapy
Extracorporeal gas flow
Time frame: Once within the first week after initiation of ECMO therapy
Length of ECMO therapy
Time frame: Daily until the end of ECMO therapy (approximately 14 days)
Cannula position and distance
Time frame: Once within the first week after initiation of ECMO therapy
Right heart dysfunction
Time frame: Once within the first week after initiation of ECMO therapy
Length of mechanical ventilation
Time frame: Entire duration of the ICU stay (approximately 28 days)
Complications of ECMO therapy
Time frame: Length of ECMO therapy (approximately 14 days)
ICU mortality
Time frame: Entire duration of the ICU stay (approximately 28 days)
ICU length of stay
Time frame: Entire duration of the ICU stay (approximately 28 days)
Incidence of ICU-acquired organ dysfunctions and complications
Time frame: Entire duration of the ICU stay (approximately 28 days)
ECMO blood flow over time
Time frame: Daily until the end of ECMO therapy (approximately 14 days)
ECMO sweep gas flow over time
Time frame: Daily until the end of ECMO therapy (approximately 14 days)
Mobility at ICU discharge
Time frame: Discharge from the ICU (approximately 28 days)
Weaning level at ICU discharge
Time frame: Discharge from the ICU (approximately 28 days)
Status of mechanical ventilation at ICU discharge
Time frame: Discharge from the ICU (approximately 28 days)
Level of organ dysfunction at ICU discharge
Time frame: Discharge from the ICU (approximately 28 days)
Level of consciousness at ICU discharge
Time frame: Discharge from the ICU (approximately 28 days)
Level of disease severity
Time frame: Discharge from the ICU (approximately 28 days)
Hospital acquired infections related to ECMO therapy
Time frame: Entire duration of ECMO therapy
Bleeding and thrombembolic complications of ECMO therapy
Time frame: Entire duration of ECMO therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Extracorporeal Membrane Oxygenation
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Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Diagnosis of ECMO Cannula Infection: Prospective Comparison of Sampling Methods
ECMO Cannula Infection, Extracorporeal Membrane Oxygenation Complication
RecruitingObservational study
Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
Not yet recruitingPhase 1/2
PACE: Prostacyclin AntiCoagulation in ECMO
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RecruitingObservational study
Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support
Drug Effect
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.
Martin Russ, Dr. med. principal investigator
Charite University Hospital Berlin
Philipp A Pickerodt, Dr. med. principal investigator
Charite University Hospital Berlin
Vladimir Skrypnikov, 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 Extracorporeal Membrane Oxygenation and Acute Respiratory Distress Syndrome, 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?
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: looking for participants now, as of the sponsor's last update on 31 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steffen Weber-Carstens, Prof. Dr. med. (0049-30450651005, steffen.weber-carstens@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful ECMO blood flow reduction (time frame: Once within the first week after initiation of ECMO therapy). 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 31 Dec 2024.