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Completed

NCT Number: NCT02020759

Cerebral Microemboli in Venoarterial ECMO Patients

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.

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Key information

Conditions

Complication of Extracorporeal Membrane Oxygenation Cerebral Microembolism Cerebral Perfusion

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Doppler Ultrasound

Device

Transcranial Doppler Ultrasound is used to monitor cerebral microembolism

Primary outcomes

  1. Cerebral embolic load

    Time frame: 30 minutes

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Cerebral Microemboli in Critically Ill Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Dec 25, 2013
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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