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Brain Swelling During Dialysis (BRASE)

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
HDF during the first examination
HD during the first examination
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Renal dialysis, Hemodiafiltration, Hemodialysis, MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

First treatment HDF

First treatment HD

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 13, 2011
Last Updated
March 21, 2012
Sponsor
University of Aarhus
Collaborators
The Danish Medical Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT01396863
Brief Title
Brain Swelling During Dialysis
Acronym
BRASE
Official Title
Acute Brain Volume Changes in Haemodialysis: Comparison of Low Flux Haemodialysis With Pre-dilution Haemodiafiltration
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Danish Medical Research Council

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Renal dialysis, Hemodiafiltration, Hemodialysis, MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First treatment HDF
Arm Type
Active Comparator
Arm 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.
Arm Title
First treatment HD
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
HDF during the first examination
Intervention Description
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
Intervention Name(s)
HD during the first examination
Intervention Description
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 Outcome Measure Information:
Title
Percent Brain Volume Change (PBVC)
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens D. Jensen, MD, PhD
Organizational Affiliation
Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Niels Johansen, BSc Medicine
Organizational Affiliation
Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Renal Medicine C, Aarhus University Hospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
The MR-Research Centre, Aarhus University Hospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

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Brain Swelling During Dialysis

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