End Stage Renal DiseaseBRASENCT01396863
Brain Swelling During Dialysis
A study testing HDF during the first examination and HD during the first examination in people with End Stage Renal Disease, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The proposed controlled, randomized study aims to compare pre-dilution hemodiafiltration (HDF) and low flux hemodialysis (HD) regarding acute changes in the brain. The study consist of two examination days placed one week apart. 12 HD patients will be recruited to the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- HDF during the first examination and HD during the first examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesDenmark
- Study dates
- Jul 2011to Feb 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Informed consent
- Patient with end-stage renal disease (ESRD)
- Stabile hemodialysis treatment (Kt/V ≥ 1.3)
- No contraindications against MRI (pacemaker or other metal implants, claustrophobia, severe adiposity)
- Weight <140kg
Who cannot join
- Clinical signs of new structural, thromboembolic or vascular brain disease the last 3 month before entering the study
- Changes in corticosteroid treatment during the last two weeks
- Change in diuretics during the last two weeks
- Non-compliant with regard to salt and fluid intake
- Acute disease
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Renal Medicine C, Aarhus University Hospital, Skejby
Aarhus N, 8200
The MR-Research Centre, Aarhus University Hospital, Skejby
Aarhus N, 8200
About this study
Official title: Acute Brain Volume Changes in Haemodialysis: Comparison of Low Flux Haemodialysis With Pre-dilution Haemodiafiltration
The proposed controlled, randomized study aims to compare pre-dilution hemodiafiltration (HDF) and low flux hemodialysis (HD) regarding acute changes in the brain.
The study consist of two examination days placed one week apart. 12 HD patients will be recruited to the study. The patients will be randomly placed in two groups: Pre-dilution hemodiafiltration during the first examination and low flux hemodialysis during the second day or vice versa.
Brain Magnetic Resonance Imaging (MRI) will be obtained before and after both treatments. The MRI-data will later be processed to estimate brain volume changes during the two types of treatment.
- Conditions
- End Stage Renal Disease
- Being tested
- HDF during the first examination, HD during the first examination
- Keywords
- Renal dialysis, Hemodiafiltration, Hemodialysis, MRI
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDF during the first examinationProcedure or surgery
The patient will receive treatment with pre-dilution hemodiafiltration during the first examination.
During the second examination the patient will receive treatment with low flux hemodialysis.
MRI of the brain will be performed before and after the treatment. The MRI-data will later be processed to determine the degree of brain volume change due to the treatment.
HD during the first examinationProcedure or surgery
The patient will receive treatment with low flux hemodialysis during the first examination.
During the second examination the patient will receive treatment with pre-dilution hemodiafiltration.
MRI of the brain will be performed before and after the treatment. The MRI-data will later be processed to determine the degree of brain volume change due to the treatment.
| Study group | Role | What they receive |
|---|---|---|
| First treatment HDF | Active comparator | The patient will receive treatment with pre-dilution hemodiafiltration during the first examination day. During the second examination day the patient will receive treatment with low flux hemodialysis. Receives: Procedure: HDF during the first examination |
| First treatment HD | Active comparator | The patient will receive treatment with low flux hemodialysis during the first examination day. During the second examination day the patient will receive treatment with pre-dilution hemodiafiltration. Receives: Procedure: HD during the first examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Brain Volume Change (PBVC)
Brain volume before and after one hemodialysis session (4,5 hours) and one session of hemodiafiltration (4,5 hours). Dialysis sessions are performed one week apart. Randomization determines the order of treatment (hemodialysis vs hemodiafiltration).
MRI-data will later be processed to estimate the PBVC.
Measured: Brain volume before and after one hemodialysis session (4,5 hours) and one session of hemodiafiltration (4,5 hours). Dialysis sessions are performed one week apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Jens D. Jensen, MD, PhD, Study director, Department of Renal Medicine C, Aarhus University Hospital, Skejby, DenmarkNiels Johansen, BSc Medicine, Principal investigator, Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396863
- Sponsor's protocol ID
- VEK20100228
- Acronym
- BRASE
- Status last verified
- Mar 2012
- First submitted
- 13 Jul 2011
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kulkarni M, Prabhu AR, Rao IR, Nagaraju SP. Interventions for preventing haemodialysis dysequilibrium syndrome. Cochrane Database Syst Rev. 2024 May 22;5(5):CD015526. doi: 10.1002/14651858.CD015526.pub2.
PubMed 38775299
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Brain Volume Changes in Haemodialysis: Comparison of Low Flux Haemodialysis With Pre-dilution Haemodiafiltration
- ClinicalTrials.gov ID
- NCT01396863
- Acronym / sponsor ID
- BRASE / VEK20100228
- Conditions
- End Stage Renal Disease
- Keywords
- Renal dialysis, Hemodiafiltration, Hemodialysis, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Jul 2011 (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.
The proposed controlled, randomized study aims to compare pre-dilution hemodiafiltration (HDF) and low flux hemodialysis (HD) regarding acute changes in the brain.
The study consist of two examination days placed one week apart. 12 HD patients will be recruited to the study. The patients will be randomly placed in two groups: Pre-dilution hemodiafiltration during the first examination and low flux hemodialysis during the second day or vice versa.
Brain Magnetic Resonance Imaging (MRI) will be obtained before and after both treatments. The MRI-data will later be processed to estimate brain volume changes during the two types of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First treatment HDF | Active comparator | Procedure: HDF during the first examinationThe patient will receive treatment with pre-dilution hemodiafiltration during the first examination day. During the second examination day the patient will receive treatment with low flux hemodialysis. |
| First treatment HD | Active comparator | Procedure: HD during the first examinationThe patient will receive treatment with low flux hemodialysis during the first examination day. During the second examination day the patient will receive treatment with pre-dilution hemodiafiltration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Informed consent
- Patient with end-stage renal disease (ESRD)
- Stabile hemodialysis treatment (Kt/V ≥ 1.3)
- No contraindications against MRI (pacemaker or other metal implants, claustrophobia, severe adiposity)
Key exclusion criteria (5 listed)
- Clinical signs of new structural, thromboembolic or vascular brain disease the last 3 month before entering the study
- Changes in corticosteroid treatment during the last two weeks
- Change in diuretics during the last two weeks
- Non-compliant with regard to salt and fluid intake
- Acute disease
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 |
|---|---|---|
| HDF during the first examinationThe patient will receive treatment with pre-dilution hemodiafiltration during the first examination. During the second examination the patient will receive treatment with low flux hemodialysis. MRI of the brain will be performed before and after the treatment. The MRI-data will later be processed to determine the degree of brain volume change due to the treatment. | Procedure or surgery | First treatment HDF |
| HD during the first examinationThe patient will receive treatment with low flux hemodialysis during the first examination. During the second examination the patient will receive treatment with pre-dilution hemodiafiltration. MRI of the brain will be performed before and after the treatment. The MRI-data will later be processed to determine the degree of brain volume change due to the treatment. | Procedure or surgery | First treatment HD |
Primary outcome
Percent Brain Volume Change (PBVC)
Time frame: Brain volume before and after one hemodialysis session (4,5 hours) and one session of hemodiafiltration (4,5 hours). Dialysis sessions are performed one week apart.
Brain volume before and after one hemodialysis session (4,5 hours) and one session of hemodiafiltration (4,5 hours). Dialysis sessions are performed one week apart. Randomization determines the order of treatment (hemodialysis vs hemodiafiltration). MRI-data will later be processed to estimate the PBVC.
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 22 Mar 2012.
- Derived from this study: PubMed 38775299Kulkarni M, Prabhu AR, Rao IR, Nagaraju SP. Interventions for preventing haemodialysis dysequilibrium syndrome. Cochrane Database Syst Rev. 2024 May 22;5(5):CD015526. doi: 10.1002/14651858.CD015526.pub2.
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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.
Jens D. Jensen, MD, PhD study director
Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark
Niels Johansen, BSc Medicine principal investigator
Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HDF during the first examination and HD during the first examination in people with End Stage Renal Disease, run by University of Aarhus at 2 sites in Denmark.
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 6 inclusion and 5 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 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Percent Brain Volume Change (PBVC) (time frame: Brain volume before and after one hemodialysis session (4,5 hours) and one session of hemodiafiltration (4,5 hours). Dialysis sessions are performed one week apart.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01396863, which also lists 1 linked publication.
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 22 Mar 2012; AzTrials last refreshed its copy on 27 Oct 2026.