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

NCT ID: NCT00150956

Last Updated: 2005-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

2002-01-31

Brief Summary

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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

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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

Conditions

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End-Stage Renal Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Daily home hemodialysis

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dianet Dialysis Centers

OTHER

Sponsor Role collaborator

Dutch Kidney Foundation

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Principal Investigators

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Pieter F Vos, MD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht, Department of Nephrology & Hypertension

Locations

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UMC Utrecht, Department of Nephrology & Hypertension

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 9829490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11158871 (View on PubMed)

Other Identifiers

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Dutch Kidney Foundation

Identifier Type: -

Identifier Source: secondary_id

C98-1750

Identifier Type: -

Identifier Source: org_study_id