Cerebral Microembolism During Hemodialysis

NCT02021045 | Completed

• 1 other identifier: 1706/2013
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Quality and laterality of cerebral embolic load

  30 minutes

Study Arms (2)

Patient on Hemodialysis

Renal hemodialysis

Device: Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany)

Patient in a hemodialysis-free interval

No Renal hemodialysis

Interventions

Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany) DEVICE

Renal replacement therapy is frequently used in patients with renal failure in order to eliminate substances obligatory excreted by the urine.

Also known as: Continuous veno-venous hemodialysis

Patient on Hemodialysis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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
• Allergy against materials of the medical device used in the study (transcranial Doppler) or temporal skin/bone lesions

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Intracranial Embolism

Interventions

Continuous Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Gabor Erdoes, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Gabor Erdoes

Study Record Dates

• First Submitted: November 20, 2013
• First Posted: December 27, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2016
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

AU (1)