Brain Swelling During Dialysis

NCT01396863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-03-22

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • The Danish Medical Research Council

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Jens D. Jensen, MD, PhD · Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark

  • Niels Johansen, BSc Medicine · Department of Renal Medicine C, Aarhus University Hospital, Skejby, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01396863 on ClinicalTrials.gov