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

This study has been completed.
Sponsor:
Collaborators:
Dianet Dialysis Centers
Dutch Kidney Foundation
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00150956
First received: September 6, 2005
Last updated: NA
Last verified: October 2000
History: No changes posted
  Purpose

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 Intervention Phase
End-Stage Renal Disease
Procedure: Daily home hemodialysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study Into the Effects of Daily Home Hemodialysis on Hemodynamics, Neurocognitive Functions, and Quality of Life

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Blood pressure at 6 months
  • Cardiac output at 6 months
  • Extracellular fluid volume at 6 months
  • Plasma renin activity at 6 months
  • Muscle sympathetic nerve activity (MSNA) at 6 months
  • Electroencephalogram (EEG) at 6 months
  • Neurocognitive functioning at 6 months
  • Quality of life at 6 months

Secondary Outcome Measures:
  • Nutritional status at 6 months

Estimated Enrollment: 12
Study Start Date: April 1999
Estimated Study Completion Date: January 2002
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00150956

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

Publications:
ClinicalTrials.gov Identifier: NCT00150956     History of Changes
Other Study ID Numbers: C98-1750, Dutch Kidney Foundation
Study First Received: September 6, 2005
Last Updated: September 6, 2005
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on July 24, 2014