Brain Swelling During Dialysis (BRASE)

This study has been completed.
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01396863
First received: July 13, 2011
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
End Stage Renal Disease
Procedure: HDF during the first examination
Procedure: HD during the first examination

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Brain Volume Changes in Haemodialysis: Comparison of Low Flux Haemodialysis With Pre-dilution Haemodiafiltration

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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.



Enrollment: 12
Study Start Date: July 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396863

Locations
Denmark
Department of Renal Medicine C, Aarhus University Hospital, Skejby
Aarhus N, Denmark, 8200
The MR-Research Centre, Aarhus University Hospital, Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
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
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01396863     History of Changes
Other Study ID Numbers: VEK20100228
Study First Received: July 13, 2011
Last Updated: March 21, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Renal dialysis
Hemodiafiltration
Hemodialysis
MRI

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on September 16, 2014