Effects of Daily Home Hemodialysis on Circulation, Mental Functions, and Quality of Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00150956
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 8, 2005
Dianet Dialysis Centers
Dutch Kidney Foundation
Information provided by:
UMC Utrecht

Brief Summary:

This study was designed to discover mechanisms responsible for the decrease in (high) blood pressure after starting daily hemodialysis, as has been observed by various investigators. We hypothesized that better control of body water and sodium content and a decline in the autonomic (sympathetic) nervous system activity, increased in chronic renal failure patients, would contribute to improved blood pressure regulation.

Moreover, we studied the effects of daily hemodialysis on mental functions, like information processing and memory, in relation to the previously reported improvement in quality of life, and the effects on nutrition. We hypothesized that all would improve.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Procedure: Daily home hemodialysis Phase 3

Detailed Description:

Although conventional hemodialysis has faced many technical improvements in recent years, a great deal of end-stage renal disease patients, treated with this modality, have suboptimal or high blood pressure, and suffer poor quality of life. Daily hemodialysis has been reported to improve both, but the pathophysiological background is poorly understood.

Patients were studied before and after 6 months of daily (i.e.6 times a week) home hemodialysis, and again after two months of conventional (i.e. thrice weekly) hemodialysis.

We measured the effects of daily dialysis (compared with conventional dialysis) on blood pressure, cardiac output, extracellular fluid volume, plasma renin activity, sympathetic nervous system activity (through MSNA), the electroencephalogram (EEG), neurocognitive functioning (speed of information processing, memory, executive functioning, and attention), quality of life, and nutritional status

Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Into the Effects of Daily Home Hemodialysis on Hemodynamics, Neurocognitive Functions, and Quality of Life
Study Start Date : April 1999
Study Completion Date : January 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Blood pressure at 6 months
  2. Cardiac output at 6 months
  3. Extracellular fluid volume at 6 months
  4. Plasma renin activity at 6 months
  5. Muscle sympathetic nerve activity (MSNA) at 6 months
  6. Electroencephalogram (EEG) at 6 months
  7. Neurocognitive functioning at 6 months
  8. Quality of life at 6 months

Secondary Outcome Measures :
  1. Nutritional status at 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • End-stage renal disease patients
  • Fit and motivated for home hemodialysis

Exclusion Criteria:

  • Patients, who were treated with frequent dialysis (5 or 6 times a week) before
  • Diabetes mellitus
  • Severe comorbidity (e.g. malignancies)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00150956

UMC Utrecht, Department of Nephrology & Hypertension
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Dianet Dialysis Centers
Dutch Kidney Foundation
Principal Investigator: Pieter F Vos, MD UMC Utrecht, Department of Nephrology & Hypertension

Publications: Identifier: NCT00150956     History of Changes
Other Study ID Numbers: C98-1750
Dutch Kidney Foundation
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 8, 2005
Last Verified: October 2000

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases