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Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 29, 2006
Last Update Posted: March 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universitaire Ziekenhuizen Leuven

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicentric Observational Study on the Removal of Protein-Bound Uremic Retention Solutes in Nocturnal Hemodialysis: A Cross-Sectional Analysis

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • removal of protein-bound retention solutes [ Time Frame: 1 dialysis session ]

Biospecimen Retention:   Samples Without DNA
serum, urine, dialysate

Enrollment: 120
Study Start Date: December 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
hemodialysis twice weekly 4 hours
Procedure: hemodialysis
group 1: twice weekly, four hours
nocturnal dialysis twice weekly 8 hours
Procedure: hemodialysis
group 2: twice weekly, eight hours
nocturnal hemodialysis, 8 hours every other night
Procedure: hemodialysis
group 3: every other day, eight hours
nocturnal hemodialysis, 8 hours, six times per week
Procedure: hemodialysis
group 4: six days a week, eight hours


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Maintenance hemodialysis patients

Inclusion Criteria:

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

Exclusion Criteria:

  • No consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417105

Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Geelong Hospital
Geelong, Victoria, Australia, 3220
Virga Jesse Ziekenhuis
Hasselt, Limburg, Belgium, 3500
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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

Responsible Party: Pieter Evenepoel, University Hospitals Leuven
ClinicalTrials.gov Identifier: NCT00417105     History of Changes
Other Study ID Numbers: NHD001
First Submitted: December 28, 2006
First Posted: December 29, 2006
Last Update Posted: March 5, 2009
Last Verified: March 2009

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

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases