Cerebral Microembolism During Hemodialysis

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.

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Key information

Conditions

Complication of Dialysis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Embolism Cerebrovascular Disorders Embolism and Thrombosis Intracranial Embolism Intracranial Embolism and Thrombosis Nervous System Diseases Thromboembolism Thrombus Due to Renal Dialysis Device, Implant, or Graft Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany)

Device

Renal replacement therapy is frequently used in patients with renal failure in order to eliminate substances obligatory excreted by the urine.

Other names: Continuous veno-venous hemodialysis

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Quantity, Quality and Laterality of Cerebral Microembolism During Veno-Venous Hemodialysis.

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2016
First posted: Dec 27, 2013
Registry last updated: Mar 4, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed