Complication of DialysisNCT02021045
Cerebral Microembolism During Hemodialysis
An observational study of Complication of Dialysis and Thrombus Due to Renal Dialysis Device, Implant, or Graft, run by Medical University of Vienna at 1 site in Austria.
Trial summary
There is increasing evidence that renal replacement therapy (= continuous veno-venous hemodialysis) generates cerebral microembolism which is detectable on transcranial Doppler ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Complication of Dialysis, Thrombus Due to Renal Dialysis Device, Implant, or Graft, Cerebral Embolism
- What is being tested?
- Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population incloses patients who are in renal failure needing renal replacement therapy under intensive care conditions.
Who may be able to join
- Renal replacement therapy (continuous veno-venous hemodilalysis) on the in-house intensive care unit
- Age > 18yrs and < 90yrs
- Allergy against materials of the medical device used in the study (transcranial Doppler) or temporal skin/bone lesions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Complication of Dialysis, Thrombus Due to Renal Dialysis Device, Implant, or Graft, Cerebral Embolism
- Being tested
- Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany)
- Medical subject headings
- Intracranial Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany)Device
Also called Continuous veno-venous hemodialysis
Renal replacement therapy is frequently used in patients with renal failure in order to eliminate substances obligatory excreted by the urine.
| Study group | Role | What they receive |
|---|---|---|
| Patient on Hemodialysis | Renal hemodialysis Receives: Device: Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany) | |
| Patient in a hemodialysis-free interval | No Renal hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of cerebral embolic load
Cerebral embolic load is measured in a 30 minutes-interval during hemodialysis and in a hemodialysis-free interval.
Measured: 30 minutes
Secondary outcomes (1)
Quality and laterality of cerebral embolic load
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of DialysisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gabor Erdoes, Medical University of Vienna
- Investigators
- Gabor Erdoes, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021045
- Sponsor's protocol ID
- 1706/2013
- Status last verified
- Mar 2016
- First submitted
- 20 Nov 2013
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantity, Quality and Laterality of Cerebral Microembolism During Veno-Venous Hemodialysis.
- ClinicalTrials.gov ID
- NCT02021045
- Acronym / sponsor ID
- 1706/2013
- Conditions
- Complication of Dialysis, Thrombus Due to Renal Dialysis Device, Implant, or Graft, Cerebral Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient on Hemodialysis | – | Device: Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany)Renal hemodialysis |
| Patient in a hemodialysis-free interval | – | –No Renal hemodialysis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population incloses patients who are in renal failure needing renal replacement therapy under intensive care conditions.
Key inclusion criteria (3 listed)
- Renal replacement therapy (continuous veno-venous hemodilalysis) on the in-house intensive care unit
- Age > 18yrs and < 90yrs
- Allergy against materials of the medical device used in the study (transcranial Doppler) or temporal skin/bone lesions
Key exclusion criteria (8 listed)
- Absent informed consent
- Preexistent neurological morbidity
- Neurocognitive disturbances
- Carotid artery stenosis > 70%
- Patent foramen ovale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany)Also: Continuous veno-venous hemodialysisRenal replacement therapy is frequently used in patients with renal failure in order to eliminate substances obligatory excreted by the urine. | Device | Patient on Hemodialysis |
Primary outcome
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.
1 secondary outcome
Quality and laterality of cerebral embolic load
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabor Erdoes, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Dialysis and Thrombus Due to Renal Dialysis Device, Implant, or Graft, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of cerebral embolic load (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2016.