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

End-Stage Renal Disease Clinical Trial

Official title:

Study Into the Effects of Daily Home Hemodialysis on Hemodynamics, Neurocognitive Functions, and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150956
• Other study ID #: C98-1750
• Secondary ID: Dutch Kidney Fou
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: September 6, 2005
• Start date: April 1999
• Est. completion date: January 2002

Study information

• Verified date: October 2000
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Procedure:
• Daily home hemodialysis

Locations

Country	Name	City	State
Netherlands	UMC Utrecht, Department of Nephrology & Hypertension	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Dianet Dialysis Centers, Dutch Kidney Foundation

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

Vos PF, Zilch O, Kooistra MP. Clinical outcome of daily dialysis. Am J Kidney Dis. 2001 Jan;37(1 Suppl 2):S99-S102. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure at 6 months
Primary	Cardiac output at 6 months
Primary	Extracellular fluid volume at 6 months
Primary	Plasma renin activity at 6 months
Primary	Muscle sympathetic nerve activity (MSNA) at 6 months
Primary	Electroencephalogram (EEG) at 6 months
Primary	Neurocognitive functioning at 6 months
Primary	Quality of life at 6 months
Secondary	Nutritional status at 6 months