Brain Swelling During Dialysis

NCT01396863 | Completed DMC

• 1 other identifier: VEK20100228
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Renal Disease

Keywords

Renal dialysis; Hemodiafiltration; Hemodialysis; MRI

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

First treatment HDF

ACTIVE COMPARATOR

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

First treatment HD

ACTIVE COMPARATOR

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

Interventions

HDF during the first examination PROCEDURE

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.

First treatment HDF

HD during the first examination PROCEDURE

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.

First treatment HD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• The Danish Medical Research Council: collaborator

Study Sites (2)

Department of Renal Medicine C, Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

The MR-Research Centre, Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

Related Publications (1)

• Kulkarni M, Prabhu AR, Rao IR, Nagaraju SP. Interventions for preventing haemodialysis dysequilibrium syndrome. Cochrane Database Syst Rev. 2024 May 22;5(5):CD015526. doi: 10.1002/14651858.CD015526.pub2.

  PMID: 38775299 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens D. Jensen, MD, PhD

  Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark

  STUDY DIRECTOR

• Niels Johansen, BSc Medicine

  Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 19, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 22, 2012

Record last verified: 2012-03

Locations

DK (2)