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Cerebral Microembolism During Hemodialysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Dr. Gabor Erdoes, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02021045
First received: November 20, 2013
Last updated: December 19, 2013
Last verified: December 2013
  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: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Quality and Distribution Pattern of Cerebral Microembolic Events During Hemodialysis - a Transcranial Doppler Study

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Cerebral embolic load [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Cerebral embolic load is measured in a 30 minutes-interval during hemodialysis and in a hemodialysis-free interval.


Secondary Outcome Measures:
  • Quality of cerebral embolic load [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Quality of cerebral embolic load (solid vs. gaseous) is measured in a 30 minutes-interval during hemodialysis and in a hemodialysis-free interval.


Estimated Enrollment: 20
Study Start Date: September 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
No Intervention: Patient in a hemodialysis-free interval
No Renal hemodialysis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Renal replacement therapy
  • Age > 18yrs.

Exclusion Criteria:

  • Inclusion in an other clinical study
  • Gravidity
  • Cerebral disease of any cause (e.g. intracerebral hemorrhage, stroke)
  • Sepsis and related conditions affecting the brain (septic cerebral embolism)
  • Allergy against materials of the medical device used in the study (transcranial Doppler)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021045

Contacts
Contact: Gabor Erdoes, MD +43 (0) 1 40400 - 4102 erdoesgabor@gmail.com
Contact: Ulrich Klein, MD +43 (0) 1 40400 - 4102 ulrich.klein@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gabor Erdoes, MD    +43 (0) 1 40400 - 4102    erdoesgabor@gmail.com   
Contact: Klaus Markstaller, MD, PhD    +43 (0) 1 40400 - 4102    klaus.markstaller@meduniwien.ac.at   
Principal Investigator: Gabor Erdoes, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gabor Erdoes, MD Medical University of Vienna
  More Information

No publications provided

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
Study First Received: November 20, 2013
Last Updated: December 19, 2013
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on November 19, 2014