Brain Swelling During Dialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-02-29

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.

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Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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First treatment HDF

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.

Group Type ACTIVE_COMPARATOR

HDF during the first examination

Intervention Type PROCEDURE

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.

First treatment HD

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.

Group Type ACTIVE_COMPARATOR

HD during the first examination

Intervention Type PROCEDURE

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.

Interventions

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HDF 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.

Intervention Type PROCEDURE

HD 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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No