Complication of Extracorporeal Membrane OxygenationNCT02020759
Cerebral Microemboli in Venoarterial ECMO Patients
An observational study of Complication of Extracorporeal Membrane Oxygenation and Cerebral Microembolism, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Extracorporeal membrane oxygenation (ECMO) is progressively used in critically ill patients with cardiac or respiratory failure as a bridging option for potential organ recovery. However, ECMO survivors often suffer from poor neurocognitive outcome due to neurological complications such as microembolic (ME) strokes. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Complication of Extracorporeal Membrane Oxygenation, Cerebral Microembolism, Cerebral Perfusion
- What is being tested?
- Transcranial Doppler Ultrasound
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2014to Mar 2019
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of three patient groups with all receiving transcranial Doppler exam: 1. patients undergoing ECMO therapy in the ICU; 2. healthy volunteers, and 3. critically ill controls (patients on the ICU without ECMO)
Who may be able to join
- Intensive care patients with cardiac or respiratory failure under va-ECMO therapy
- Age > 18 yrs.
- Signed informed consent
- gravidity
- allergy against materials of one of the medical device used in the study
Who cannot join
- use of any other extracorporeal device including venovenous (vv) ECMO
- continuous renal replacement therapy
- medical history of severe mitral or aortic stenosis
- medical history of severe mitral or aortic regurgitation
- medical history of carotid stenosis > 70 %
- septicaemia
- medical history of vascular dementia or Alzheimer's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Microemboli in Critically Ill Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation
Extracorporeal membrane oxygenation (ECMO) is progressively used in critically ill patients with cardiac or respiratory failure as a bridging option for potential organ recovery. However, ECMO survivors often suffer from poor neurocognitive outcome due to neurological complications such as microembolic (ME) strokes.
In venoarterial (va) ECMO circuits the pulmonary circulation, which usually serves as microembolic filter, may be bypassed and generated ME are prone to reach the brain in substantial amounts and potentially impair cerebral integrity. Although patient exposure to cerebral ME has been thoroughly investigated in cardiopulmonary bypass procedures, there is only limited research on cerebral ME in patients undergoing ECMO therapy.
The primary study goal of this study is to determine the load and nature of cerebral ME in critically ill patients under va-ECMO support. We also aim to compare the results to measurements in healthy subjects und intensive care unit (ICU) patients without extracorporeal support to get a better impression on the relevance of ME generation during ECMO support.
Read the detailed description
The addition of ICU patients was made according to reviewer suggestions after an initial submission to a medical journal.
- Conditions
- Complication of Extracorporeal Membrane Oxygenation, Cerebral Microembolism, Cerebral Perfusion
- Being tested
- Transcranial Doppler Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Doppler UltrasoundDevice
Transcranial Doppler Ultrasound is used to monitor cerebral microembolism
| Study group | Role | What they receive |
|---|---|---|
| Patient on ECMO | Neurological monitoring with transcranial Doppler ultrasound Receives: Device: Transcranial Doppler Ultrasound | |
| Healthy subjects | Neurological monitoring with transcranial Doppler ultrasound Receives: Device: Transcranial Doppler Ultrasound | |
| ICU patients | Neurological monitoring with transcranial Doppler ultrasound Receives: Device: Transcranial Doppler Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral embolic load
Cerebral embolic load (solid and gaseous) is measured in a 30 minutes-interval during ECMO usage
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startJun 2014
- Primary completionAug 2018
- Study completionMar 2019
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 Complication of Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gabor Erdoes, Medical University of Vienna
- Investigators
- Gabor Erdoes, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020759
- Sponsor's protocol ID
- 1557/2013
- Status last verified
- May 2019
- First submitted
- 19 Dec 2013
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kietaibl C, Horvat Menih I, Engel A, Ullrich R, Klein KU, Erdoes G. Cerebral microemboli during extracorporeal life support: a single-centre cohort study. Eur J Cardiothorac Surg. 2021 Dec 27;61(1):172-179. doi: 10.1093/ejcts/ezab353.
PubMed 34406372
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Microemboli in Critically Ill Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT02020759
- Acronym / sponsor ID
- 1557/2013
- Conditions
- Complication of Extracorporeal Membrane Oxygenation, Cerebral Microembolism, Cerebral Perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 25 Dec 2013 (estimated)
- 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.
Extracorporeal membrane oxygenation (ECMO) is progressively used in critically ill patients with cardiac or respiratory failure as a bridging option for potential organ recovery. However, ECMO survivors often suffer from poor neurocognitive outcome due to neurological complications such as microembolic (ME) strokes.
In venoarterial (va) ECMO circuits the pulmonary circulation, which usually serves as microembolic filter, may be bypassed and generated ME are prone to reach the brain in substantial amounts and potentially impair cerebral integrity. Although patient exposure to cerebral ME has been thoroughly investigated in cardiopulmonary bypass procedures, there is only limited research on cerebral ME in patients undergoing ECMO therapy.
The primary study goal of this study is to determine the load and nature of cerebral ME in critically ill patients under va-ECMO support. We also aim to compare the results to measurements in healthy subjects und intensive care unit (ICU) patients without extracorporeal support to get a better impression on the relevance of ME generation during ECMO support.
Detailed description
The addition of ICU patients was made according to reviewer suggestions after an initial submission to a medical journal.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient on ECMO | – | Device: Transcranial Doppler UltrasoundNeurological monitoring with transcranial Doppler ultrasound |
| Healthy subjects | – | Device: Transcranial Doppler UltrasoundNeurological monitoring with transcranial Doppler ultrasound |
| ICU patients | – | Device: Transcranial Doppler UltrasoundNeurological monitoring with transcranial Doppler ultrasound |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of three patient groups with all receiving transcranial Doppler exam: 1. patients undergoing ECMO therapy in the ICU; 2. healthy volunteers, and 3. critically ill controls (patients on the ICU without ECMO)
Key inclusion criteria (5 listed)
- Intensive care patients with cardiac or respiratory failure under va-ECMO therapy
- Age > 18 yrs.
- Signed informed consent
- gravidity
- allergy against materials of one of the medical device used in the study
Key exclusion criteria (7 listed)
- use of any other extracorporeal device including venovenous (vv) ECMO
- continuous renal replacement therapy
- medical history of severe mitral or aortic stenosis
- medical history of severe mitral or aortic regurgitation
- medical history of carotid stenosis > 70 %
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 |
|---|---|---|
| Transcranial Doppler UltrasoundTranscranial Doppler Ultrasound is used to monitor cerebral microembolism | Device | Healthy subjects, ICU patients, Patient on ECMO |
Primary outcome
Cerebral embolic load
Time frame: 30 minutes
Cerebral embolic load (solid and gaseous) is measured in a 30 minutes-interval during ECMO usage
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 8 May 2019.
- Derived from this study: PubMed 34406372Kietaibl C, Horvat Menih I, Engel A, Ullrich R, Klein KU, Erdoes G. Cerebral microemboli during extracorporeal life support: a single-centre cohort study. Eur J Cardiothorac Surg. 2021 Dec 27;61(1):172-179. doi: 10.1093/ejcts/ezab353.
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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.
Gabor Erdoes, MD principal investigator
Medical University of Vienna
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 Complication of Extracorporeal Membrane Oxygenation and Cerebral Microembolism, run by Medical University of Vienna at 1 site in Austria.
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 5 inclusion and 7 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 8 May 2019. 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 Austria. 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?
Cerebral embolic load (time frame: 30 minutes). 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 NCT02020759, 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 8 May 2019.