Cerebral Microemboli in Venoarterial ECMO Patients

Cerebral Perfusion Clinical Trial

Official title:

Cerebral Microemboli in Critically Ill Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020759
• Other study ID #: 1557/2013
• Status: Completed
• Start date: June 2014
• Est. completion date: March 2019

Study information

• Verified date: May 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Microembolism
• Cerebral Perfusion
• Complication of Extracorporeal Membrane Oxygenation

Intervention

Device:
• Transcranial Doppler Ultrasound
Transcranial Doppler Ultrasound is used to monitor cerebral microembolism

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral embolic load	Cerebral embolic load (solid and gaseous) is measured in a 30 minutes-interval during ECMO usage	30 minutes