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CompletedNCT00150956Updated Sep 8, 2005

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

A Phase 3 interventional study of Daily home hemodialysis in End-Stage Renal Disease, sponsored by UMC Utrecht. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-09-08.

Sponsored by UMC Utrecht · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • End-Stage Renal Disease
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 12 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients, who were treated with frequent dialysis (5 or 6 times a week) before
  • Diabetes mellitus
  • Severe comorbidity (e.g. malignancies)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants

Interventions

  • ProcedureDaily home hemodialysis
06

What researchers measure

Primary outcomes

  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 outcomes

  1. Nutritional status at 6 months

07

Study locations

1 site
  • UMC Utrecht, Department of Nephrology & Hypertension
    Utrecht, 3584 CX, Netherlands
08

References and documents

Publications

  • Kooistra MP, Vos J, Koomans HA, Vos PF. Daily home haemodialysis in The Netherlands: effects on metabolic control, haemodynamics, and quality of life. Nephrol Dial Transplant. 1998 Nov;13(11):2853-60. doi: 10.1093/ndt/13.11.2853. PubMed 9829490 ↗
  • Vos PF, Zilch O, Kooistra MP. Clinical outcome of daily dialysis. Am J Kidney Dis. 2001 Jan;37(1 Suppl 2):S99-S102. doi: 10.1053/ajkd.2001.20761. PubMed 11158871 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00150956
Lead sponsor
UMC Utrecht
Collaborators
Dianet Dialysis Centers, Dutch Kidney Foundation
First posted
Sep 8, 2005
Start date
Apr 1999
Completion
Jan 2002
Last update
Sep 8, 2005

Study contacts

Pieter F Vos, MD
principal investigator · UMC Utrecht, Department of Nephrology & Hypertension
View the source record on ClinicalTrials.gov ↗

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