Brain Swelling During Dialysis

Study Overview
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Brief Summary
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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.

Official Title
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Acute Brain Volume Changes in Haemodialysis: Comparison of Low Flux Haemodialysis With Pre-dilution Haemodiafiltration

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Procedure: HDF during the first examination
* Procedure: HD during the first examination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First treatment HDF<br>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. | Procedure: HDF during the first examination<br>* 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.<br>|
| Active Comparator: First treatment HD<br>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. | Procedure: HD during the first examination<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Renal dialysis, Hemodiafiltration, Hemodialysis