Cerebral Microembolism During Hemodialysis

March 3, 2016 updated by: Dr. Gabor Erdoes, Medical University of Vienna

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • Continuous veno-venous hemodialysis
Patient in a hemodialysis-free interval
No Renal hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Gabor Erdoes, MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 20, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Estimate)

March 4, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1706/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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