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

NCT00150956 | Completed Phase 3

• 2 other identifiers: C98-1750Dutch Kidney Foundation
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

End-Stage Renal Disease

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Nutritional status at 6 months

Interventions

Daily home hemodialysis PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• UMC Utrecht: lead
• Dianet Dialysis Centers: collaborator
• Dutch Kidney Foundation: collaborator

Study Sites (1)

UMC Utrecht, Department of Nephrology & Hypertension

Utrecht, 3584 CX, Netherlands

Location

Related 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. doi: 10.1093/ndt/13.11.2853.

  PMID: 9829490 BACKGROUND

• 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.

  PMID: 11158871 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Pieter F Vos, MD

  UMC Utrecht, Department of Nephrology & Hypertension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: April 1, 1999
• Study Completion: January 1, 2002
• Last Updated: September 8, 2005

Record last verified: 2000-10

Locations

NL (1)