Brain Swelling During Dialysis

End Stage Renal Disease Clinical Trial

— BRASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396863
• Other study ID #: VEK20100228
• Status: Completed
• Phase: N/A
• First received: July 13, 2011
• Last updated: March 21, 2012
• Start date: July 2011
• Est. completion date: February 2012

Study information

• Verified date: March 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Department of Renal Medicine C, Aarhus University Hospital, Skejby	Aarhus N
Denmark	The MR-Research Centre, Aarhus University Hospital, Skejby	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No