Brain Swelling During Dialysis (BRASE)

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Procedure: HDF during the first examination; Procedure: HD during the first examination

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Department of Renal Medicine C, Aarhus University Hospital, Skejby
  • Aarhus N, Denmark, 8200
    • The MR-Research Centre, Aarhus University Hospital, Skejby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Active Comparator: 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.	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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: The Danish Medical Research Council
• Investigators: Study Director: Jens D. Jensen, MD, PhD, Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark; Principal Investigator: Niels Johansen, BSc Medicine, Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: July 13, 2011
• First Submitted That Met QC Criteria: July 15, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): March 22, 2012
• Last Update Submitted That Met QC Criteria: March 21, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: MRI; Hemodialysis; Renal dialysis; Hemodiafiltration
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: VEK20100228