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Cerebral Microemboli in Venoarterial ECMO Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020759
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Gabor Erdoes, 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.


Condition or disease Intervention/treatment
Complication of Extracorporeal Membrane Oxygenation Cerebral Microembolism Cerebral Perfusion 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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Microemboli in Critically Ill Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation
Actual Study Start Date : June 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : March 2019

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




Primary Outcome Measures :
  1. Cerebral embolic load [ Time Frame: 30 minutes ]
    Cerebral embolic load (solid and gaseous) is measured in a 30 minutes-interval during ECMO usage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020759


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Gabor Erdoes, MD Medical University of Vienna
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Responsible Party: Dr. Gabor Erdoes, Dr Gabor Erdoes, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02020759    
Other Study ID Numbers: 1557/2013
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019