Brain Swelling During Dialysis

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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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Renal Medicine C, Aarhus University Hospital, Skejby, Aarhus N, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HDF during the first examination

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.

HD during the first examination

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

The Danish Medical Research Council

Registry information

Official study title

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

Acronym: BRASE

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jul 19, 2011
Registry last updated: Mar 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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