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Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis
This study is currently recruiting participants.
Verified by Universitaire Ziekenhuizen Leuven, March 2008
Sponsored by: Universitaire Ziekenhuizen Leuven
Information provided by: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT00417105
  Purpose

Although remarkable progress has been made, chronic kidney disease still poses a major burden on both individual patients, as well as on society as a whole. There is a strong inverse relationship between decreasing renal function, as estimated by glomerular filtration rate, and mortality rate, especially death due to cardiovascular disease. The exact cause(s) remain to be elucidated. Uremic toxins might play an important role.

In the course of decreasing renal function the concentration of numerous intracellular and extracellular compounds vary from the non-uremic state. But still increasing number of uremic retention solutes are being identified. Renal replacement strategies aim to remove potentially harmful substances from the body. Traditionally much attention has been paid to small water-soluble molecules such as urea nitrogen and creatinine. Based on the results of the recent HEMO and ADEMEX studies, increases of small water-soluble solute removal above the level reached with modern dialysis techniques - hemodialysis, peritoneal dialysis (HD, PD) - seem not to be advantageous with regard to patient outcome. These findings may point to the importance of other distinct groups of uremic retention solutes. In view of the data described above, protein-bound solutes might be good candidates.

Several advantages of long duration hemodialysis have been observed, including a better control of blood pressure by decreasing extracellular fluid volume, lowering peripheral vascular resistance and improving endothelium-dependent and -independent vasodilation. A normalization of heart rate variability and improvement of left-ventricular function was noted as well. Furthermore, anemia control has been shown to be easier and several nutritional parameters improved in patients treated with long duration HD. The therapy results in higher small water-soluble solute removal, phosphate removal and greater elimination of larger molecules (e.g. β2-microglobulin).

It seems an appealing question whether a better control of the serum levels of protein-bound solutes can be achieved by long duration (nocturnal) hemodialysis. This might be another advantage of this therapeutic modality, or may even in part explain the better outcome of patients treated this way.

The study compares intermittent hemodialysis with long nocturnal hemodialysis with respect to serum concentrations of several protein bound uremic toxins, as well as solute removal.


Condition Intervention
End Stage Renal Disease
Procedure: hemodialysis

MedlinePlus related topics: Dialysis Drinking Water Kidney Failure
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: A Multicentric Observational Study on the Removal of Protein-Bound Uremic Retention Solutes in Nocturnal Hemodialysis: A Cross-Sectional Analysis

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • removal of protein-bound retention solutes [ Time Frame: 1 dialysis session ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

serum, urine, dialysate


Estimated Enrollment: 150
Study Start Date: December 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
hemodialysis twice weekly 4 hours
Procedure: hemodialysis
group 1: twice weekly, four hours
2
nocturnal dialysis twice weekly 8 hours
Procedure: hemodialysis
group 2: twice weekly, eight hours
3
nocturnal hemodialysis, 8 hours every other night
Procedure: hemodialysis
group 3: every other day, eight hours
4
nocturnal hemodialysis, 8 hours, six times per week
Procedure: hemodialysis
group 4: six days a week, eight hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Maintenance hemodialysis patients

Criteria

Inclusion Criteria:

  • Age > 18 years
  • Maintenance hemodialysis (> 3 months duration)
  • Informed consent

Exclusion Criteria:

  • No consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417105

Contacts
Contact: Björn KI Meijers, MD 00 32 (0)16 342352 bjorn.meijers@uz.kuleuven.ac.be
Contact: Pieter Evenepoel, MD, PhD 00 32 (0)16 344580 pieter.evenepoel@uz.kuleuven.ac.be

Locations
Australia, Victoria
Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
Contact: Nigel Toussaint, MD     +61 3 9594 3529     nigel.toussaint@med.monash.edu.au    
Contact: Peter Kerr, MD     + 61 3 9594 3529     peter.kerr@med.monash.edu.au    
Principal Investigator: Nigel Toussaint, MD            
Principal Investigator: Peter Kerr, MD            
Sub-Investigator: Kevan Polkinhorne            
Geelong Hospital Recruiting
Geelong, Victoria, Australia, 3220
Contact: John Agar, MD     +61 3 5226 7499     johna@barwonhealth.org.au    
Principal Investigator: John Agar, MD            
Belgium, Limburg
Virga Jesse Ziekenhuis Recruiting
Hasselt, Limburg, Belgium, 3500
Contact: Tom Dejagere, MD     00 32 (0)11 308111     tom.dejagere@virgajesse.be    
Principal Investigator: Tom Dejagere, MD            
Belgium, Vlaams-Brabant
Universitaire Ziekenhuizen Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Björn KI Meijers, MD     00 32 (0)16 342352     bjorn.meijers@uz.kuleuven.ac.be    
Principal Investigator: Björn KI Meijers, MD            
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Björn KI Meijers, MD Universitaire Ziekenhuizen Leuven
Study Director: Pieter Evenepoel, MD, PhD Universitaire Ziekenhuizen Leuven
Principal Investigator: Tom Dejagere, MD Virga Jesse Ziekenhuis
Principal Investigator: Nigel Toussaint, MD Geelong Hospital
  More Information

Publications:
Responsible Party: University Hospitals Leuven ( Pieter Evenepoel )
Study ID Numbers: NHD001
Study First Received: December 28, 2006
Last Updated: July 22, 2008
ClinicalTrials.gov Identifier: NCT00417105  
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
hemodialysis, dialysis adequacy, chronic kidney disease

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Urinary Retention
Kidney Failure

ClinicalTrials.gov processed this record on January 16, 2009