Cerebral Microemboli in Venoarterial ECMO Patients

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Perfusion; Complication of Extracorporeal Membrane Oxygenation; Cerebral Microembolism
• Intervention / Treatment: Device: Transcranial Doppler Ultrasound

Detailed Description

The addition of ICU patients was made according to reviewer suggestions after an initial submission to a medical journal.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient on ECMO; Neurological monitoring with transcranial Doppler ultrasound	Device: Transcranial Doppler Ultrasound; Transcranial Doppler Ultrasound is used to monitor cerebral microembolism
Healthy subjects; Neurological monitoring with transcranial Doppler ultrasound	Device: Transcranial Doppler Ultrasound; Transcranial Doppler Ultrasound is used to monitor cerebral microembolism
ICU patients; Neurological monitoring with transcranial Doppler ultrasound	Device: Transcranial Doppler Ultrasound; Transcranial Doppler Ultrasound is used to monitor cerebral microembolism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral embolic load	Cerebral embolic load (solid and gaseous) is measured in a 30 minutes-interval during ECMO usage	30 minutes

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Gabor Erdoes, MD, Medical University of Vienna

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: December 24, 2013
• First Posted (Estimate): December 25, 2013

Study Record Updates

• Last Update Posted (Actual): May 8, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1557/2013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No