Cerebral Microembolism During Hemodialysis

Completed

• Conditions: Cerebral Embolism; Complication of Dialysis; Thrombus Due to Renal Dialysis Device, Implant, or Graft
• Interventions: Device: Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany)

• Registration Number: NCT02021045
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-20
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-27
• Primary Completion: 2015-11
• Status Verified: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient on Hemodialysis	Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany)	Renal hemodialysis

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality and laterality of cerebral embolic load	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.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria