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

Primary Purpose

End-Stage Renal Disease

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Daily home hemodialysis
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UMC Utrecht, Department of Nephrology & Hypertension

Outcomes

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

Full Information

First Posted
September 6, 2005
Last Updated
September 6, 2005
Sponsor
UMC Utrecht
Collaborators
Dianet Dialysis Centers, Dutch Kidney Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00150956
Brief Title
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

2. Study Status

Record Verification Date
October 2000
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
UMC Utrecht
Collaborators
Dianet Dialysis Centers, Dutch Kidney Foundation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Daily home hemodialysis
Primary Outcome Measure Information:
Title
Blood pressure at 6 months
Title
Cardiac output at 6 months
Title
Extracellular fluid volume at 6 months
Title
Plasma renin activity at 6 months
Title
Muscle sympathetic nerve activity (MSNA) at 6 months
Title
Electroencephalogram (EEG) at 6 months
Title
Neurocognitive functioning at 6 months
Title
Quality of life at 6 months
Secondary Outcome Measure Information:
Title
Nutritional status at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieter F Vos, MD
Organizational Affiliation
UMC Utrecht, Department of Nephrology & Hypertension
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Utrecht, Department of Nephrology & Hypertension
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
9829490
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.
Results Reference
background
PubMed Identifier
11158871
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.
Results Reference
background

Learn more about this trial

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

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