Clinical trial NCT00150956: Effects of Daily Home Hemodialysis on Circulation, Mental Functions, and Quality of Life
Official title: Study Into the Effects of Daily Home Hemodialysis on Hemodynamics, Neurocognitive Functions, and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: End-Stage Renal Disease
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Dianet Dialysis Centers
name: Dutch Kidney Foundation
First posted: 2005-09-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Blood pressure at 6 months
measure: Cardiac output at 6 months
measure: Extracellular fluid volume at 6 months
measure: Plasma renin activity at 6 months
measure: Muscle sympathetic nerve activity (MSNA) at 6 months
measure: Electroencephalogram (EEG) at 6 months
measure: Neurocognitive functioning at 6 months
measure: Quality of life at 6 months
Secondary outcomes:
measure: Nutritional status at 6 months
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht, Department of Nephrology & Hypertension
Study officials:
affiliation: UMC Utrecht, Department of Nephrology & Hypertension
name: Pieter F Vos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.