Cerebral Microembolism During Hemodialysis

Cerebral Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021045
• Other study ID #: 1706/2013
• Status: Completed
• Phase: N/A
• First received: November 20, 2013
• Last updated: March 3, 2016
• Start date: September 2013
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Embolism
• Complication of Dialysis
• Thrombus Due to Renal Dialysis Device, Implant, or Graft

Intervention

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.

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	Quantity of cerebral embolic load	Cerebral embolic load is measured in a 30 minutes-interval during hemodialysis and in a hemodialysis-free interval.	30 minutes	No
Secondary	Quality and laterality of cerebral embolic load	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.	30 minutes	No