Cerebral Microemboli in Venoarterial ECMO Patients

NCT02020759 | Completed

• 1 other identifier: 1557/2013
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication of Extracorporeal Membrane Oxygenation; Cerebral Microembolism; Cerebral Perfusion

Outcome Measures

Primary Outcomes (1)

• Cerebral embolic load

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

  30 minutes

Study Arms (3)

Patient on ECMO

Neurological monitoring with transcranial Doppler ultrasound

Device: Transcranial Doppler Ultrasound

Healthy subjects

Neurological monitoring with transcranial Doppler ultrasound

Device: Transcranial Doppler Ultrasound

ICU patients

Neurological monitoring with transcranial Doppler ultrasound

Device: Transcranial Doppler Ultrasound

Interventions

Transcranial Doppler Ultrasound DEVICE

Transcranial Doppler Ultrasound is used to monitor cerebral microembolism

Healthy subjects; ICU patients; Patient on ECMO

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Intensive care patients with cardiac or respiratory failure under va-ECMO therapy
• Age \> 18 yrs.
• Signed informed consent

You may not qualify if:

• 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
• gravidity
• allergy against materials of one of the medical device used in the study

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 34406372 DERIVED

MeSH Terms

Interventions

Ultrasonography, Doppler, Transcranial

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Gabor Erdoes, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Gabor Erdoes

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 25, 2013
• Study Start: June 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: March 1, 2019
• Last Updated: May 8, 2019

Record last verified: 2019-05

Locations

AU (1)