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

Phase 3

Completed

• Conditions: End-Stage Renal Disease

• Registration Number: NCT00150956
• Lead Sponsor: UMC Utrecht

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

Study Timeline

• Study Start: 1999-04
• Status Verified: 2000-10
• Study Completion: 2002-01
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Last Update Submitted: 2005-09-06
• Study First Posted: 2005-09-08
• Last Update Posted: 2005-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Nutritional status at 6 months

Trial Locations

Locations (1)

UMC Utrecht, Department of Nephrology & Hypertension; 🇳🇱 Utrecht, Netherlands