Cerebral Microembolism During Hemodialysis

Overview

There is increasing evidence that renal replacement therapy (= continuous veno-venous hemodialysis) generates cerebral microembolism which is detectable on transcranial Doppler ultrasound. The aim of this study is to monitor patients with transcranial Doppler under two conditions: during hemodialysis and in a hemodialysis-free interval (in each period cerebral embolic load is detected during 30 minutes). The study hypothesis is that during hemodialysis the cerebral embolic load is significantly higher than in the hemodialysis-free interval.

Full Title of Study: “Quantity, Quality and Laterality of Cerebral Microembolism During Veno-Venous Hemodialysis.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2015

Interventions

  • Device: Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany)
    • Renal replacement therapy is frequently used in patients with renal failure in order to eliminate substances obligatory excreted by the urine.

Arms, Groups and Cohorts

  • Patient on Hemodialysis
    • Renal hemodialysis
  • Patient in a hemodialysis-free interval
    • No Renal hemodialysis

Clinical Trial Outcome Measures

Primary Measures

  • Quantity of cerebral embolic load
    • Time Frame: 30 minutes
    • Cerebral embolic load is measured in a 30 minutes-interval during hemodialysis and in a hemodialysis-free interval.

Secondary Measures

  • Quality and laterality of cerebral embolic load
    • Time Frame: 30 minutes
    • Quality (solid vs. gaseous) and laterality (left vs. right hemispheric dominance) of cerebral embolic load is measured in a 30 minutes-interval during hemodialysis and in a hemodialysis-free interval.

Participating in This Clinical Trial

Inclusion Criteria

  • Renal replacement therapy (continuous veno-venous hemodilalysis) on the in-house intensive care unit – Age > 18yrs and < 90yrs Exclusion Criteria:

  • Absent informed consent – Preexistent neurological morbidity – Neurocognitive disturbances – Carotid artery stenosis > 70% – Patent foramen ovale – Treatment with other extracorporeal devices – Cardial pathology (valvular heart disease, prosthesis, endocarditis) – Pregnancy, drug abuse – Inclusion in an other clinical study – Allergy against materials of the medical device used in the study (transcranial Doppler) or temporal skin/bone lesions

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Vienna
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Gabor Erdoes, Dr Gabor Erdoes – Medical University of Vienna
  • Overall Official(s)
    • Gabor Erdoes, MD, Principal Investigator, Medical University of Vienna

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.