Cerebral Microemboli in Venoarterial ECMO Patients

Completed

• Conditions: Complication of Extracorporeal Membrane Oxygenation; Cerebral Microembolism; Cerebral Perfusion
• Interventions: Device: Transcranial Doppler Ultrasound

• Registration Number: NCT02020759
• Lead Sponsor: Medical University of Vienna

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-24
• Study First Posted: 2013-12-25
• Study Start: 2014-06
• Primary Completion: 2018-08
• Study Completion: 2019-03
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Transcranial Doppler Ultrasound	Neurological monitoring with transcranial Doppler ultrasound
Patient on ECMO	Transcranial Doppler Ultrasound	Neurological monitoring with transcranial Doppler ultrasound
ICU patients	Transcranial Doppler Ultrasound	Neurological monitoring with transcranial Doppler ultrasound

Primary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria