Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis

This study has been completed.
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00417105
First received: December 28, 2006
Last updated: March 4, 2009
Last verified: March 2009
  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

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 ] [ Designated as safety issue: No ]

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417105

Locations
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Geelong Hospital
Geelong, Victoria, Australia, 3220
Belgium
Virga Jesse Ziekenhuis
Hasselt, Limburg, Belgium, 3500
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
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: Pieter Evenepoel, University Hospitals Leuven
ClinicalTrials.gov Identifier: NCT00417105     History of Changes
Other Study ID Numbers: NHD001
Study First Received: December 28, 2006
Last Updated: March 4, 2009
Health Authority: Belgium: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 21, 2014