Brain Swelling During Dialysis

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Procedure: HDF during the first examination; Procedure: HD during the first examination

• Registration Number: NCT01396863
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-15
• Study First Posted: 2011-07-19
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-21
• Last Update Posted: 2012-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First treatment HDF	HDF during the first examination	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.
First treatment HD	HD during the first examination	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.

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (2)

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

The MR-Research Centre, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus N, Denmark