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Cerebral Microemboli in Venoarterial ECMO Patients

Cerebral Microemboli in Critically Ill Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02020759
Enrollment
20
Registered
2013-12-25
Start date
2014-06-30
Completion date
2019-03-31
Last updated
2019-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Extracorporeal Membrane Oxygenation, Cerebral Microembolism, Cerebral Perfusion

Brief 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. 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.

Interventions

Transcranial Doppler Ultrasound is used to monitor cerebral microembolism

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

(for patients): * Intensive care patients with cardiac or respiratory failure under va-ECMO therapy * Age \> 18 yrs. * Signed informed consent

Exclusion criteria

* 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 * inclusion in an other clinical study * gravidity * allergy against materials of one of the medical device used in the study

Design outcomes

Primary

MeasureTime frameDescription
Cerebral embolic load30 minutesCerebral embolic load (solid and gaseous) is measured in a 30 minutes-interval during ECMO usage

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026