Brain Swelling During Dialysis (BRASE)

University of Aarhus

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Procedure: HDF during the first examination; Procedure: HD during the first examination

Study type: Interventional

Funder types: Other

Identifiers

NCT01396863

VEK20100228

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

First treatment HDF

Active Comparator group

Description:

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.

Treatment:

Procedure: HDF during the first examination

First treatment HD

Active Comparator group

Description:

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.

Treatment:

Procedure: HD during the first examination