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Cerebral Microembolism During Hemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02021045
First Posted: December 27, 2013
Last Update Posted: March 4, 2016
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.
Information provided by (Responsible Party):
Dr. Gabor Erdoes, Medical University of Vienna
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantity, Quality and Laterality of Cerebral Microembolism During Veno-Venous Hemodialysis.

Resource links provided by NLM:


Further study details as provided by Dr. Gabor Erdoes, Medical University of Vienna:

Primary Outcome 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 Outcome 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.


Enrollment: 40
Study Start Date: September 2013
Study Completion Date: March 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient on Hemodialysis
Renal hemodialysis
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.
Other Name: Continuous veno-venous hemodialysis
Patient in a hemodialysis-free interval
No Renal hemodialysis

  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population incloses patients who are in renal failure needing renal replacement therapy under intensive care conditions.
Criteria

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
  Contacts and Locations
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): NCT02021045


Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gabor Erdoes, MD Medical University of Vienna
  More Information

Responsible Party: Dr. Gabor Erdoes, Dr Gabor Erdoes, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02021045     History of Changes
Other Study ID Numbers: 1706/2013
First Submitted: November 20, 2013
First Posted: December 27, 2013
Last Update Posted: March 4, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Embolism
Thrombosis
Intracranial Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Intracranial Embolism and Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Thromboembolism