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Completed

NCT Number: NCT00150956

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

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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UMC Utrecht, Department of Nephrology & Hypertension

Utrecht, 3584 CX, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Daily home hemodialysis

Procedure

Primary outcomes

  1. Blood pressure at 6 months

  2. Cardiac output at 6 months

  3. Extracellular fluid volume at 6 months

  4. Plasma renin activity at 6 months

  5. Muscle sympathetic nerve activity (MSNA) at 6 months

  6. Electroencephalogram (EEG) at 6 months

  7. Neurocognitive functioning at 6 months

  8. Quality of life at 6 months

Secondary outcomes

  1. Nutritional status at 6 months

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Dianet Dialysis Centers
  • Dutch Kidney Foundation

Registry information

Official study title

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

Important dates

Study start
1999
Study completion
2002
First posted
Sep 8, 2005
Registry last updated
Sep 8, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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