Protein-bound Uremic Retention Solutes and Long Nocturnal Hemodialysis: a Longitudinal Analysis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Björn Meijers, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00417339
First received: December 28, 2006
Last updated: December 16, 2013
Last verified: December 2013
  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. A 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 (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 Kidney Disease
Procedure: hemodialysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentric Observational Trial on Protein Bound Uremic Toxins in Nocturnal Hemodialysis

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Biospecimen Retention:   Samples Without DNA

serum, urine, dialysate


Estimated Enrollment: 20
Study Start Date: December 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
hemodialysis, four hours, twice weekly
Procedure: hemodialysis
individualised
2
hemodialysis, eight hours, twice weekly
Procedure: hemodialysis
individualised
3
hemodialysis, eight hours, every other day
Procedure: hemodialysis
individualised
4
hemodialysis, eight hours, six days per week
Procedure: hemodialysis
individualised

  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 dialysis patients

Criteria

Inclusion Criteria:

  • Start hemodialysis during 2007
  • Age over 18 years
  • Informed consent

Exclusion Criteria:

  • Non 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: NCT00417339

Locations
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Geelong Hospital
Geelong, Victoria, Australia, 3220
Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Brabant, Belgium, 3000
Virga Jesseziekenhuis
Hasselt, Limburg, Belgium, 3500
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: Björn Meijers, Prof, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT00417339     History of Changes
Other Study ID Numbers: NHD002
Study First Received: December 28, 2006
Last Updated: December 16, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
hemodialysis
dialysis adequacy
uremic retention solute

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

ClinicalTrials.gov processed this record on September 18, 2014