Clinical trial NCT02020759: Cerebral Microemboli in Venoarterial ECMO Patients
Official title: Cerebral Microemboli in Critically Ill Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Extracorporeal Membrane Oxygenation
Cerebral Microembolism
Cerebral Perfusion
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-12-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cerebral embolic load
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Gabor Erdoes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.