End Stage Renal Disease
Conditions
Keywords
Renal dialysis, Hemodiafiltration, Hemodialysis, MRI
Brief 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. 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.
Interventions
PROCEDUREHDF during the first examination
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.
PROCEDUREHD during the first examination
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.
Sponsors
The Danish Medical Research Council
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Denmark
Outcome results
None listed