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

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. Identifier: NCT00417339
Recruitment Status : Completed
First Posted : January 1, 2007
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):
Björn Meijers, Universitaire Ziekenhuizen Leuven

Brief Summary:
Study on intradialytic kinetics of protein-bound uremic retention solutes during long nocturnal hemodialysis

Condition or disease Intervention/treatment
End Stage Kidney Disease Procedure: hemodialysis

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentric Observational Trial on Protein Bound Uremic Toxins in Nocturnal Hemodialysis
Study Start Date : December 2006
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Group/Cohort Intervention/treatment
hemodialysis, 4h, twice weekly
hemodialysis, four hours, twice weekly
Procedure: hemodialysis
hemodialysis, 8h, twice weekly
hemodialysis, eight hours, twice weekly
Procedure: hemodialysis
hemodialysis, 8h, every other day
hemodialysis, eight hours, every other day
Procedure: hemodialysis
hemodialysis, 8h, six days per week
hemodialysis, eight hours, six days per week
Procedure: hemodialysis

Biospecimen Retention:   Samples Without DNA
serum, urine, dialysate

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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 dialysis patients

Inclusion Criteria:

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

Exclusion Criteria:

  • Non consent

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 identifier (NCT number): NCT00417339

Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Geelong Hospital
Geelong, Victoria, Australia, 3220
Universitaire Ziekenhuizen Leuven
Leuven, Brabant, Belgium, 3000
Virga Jesseziekenhuis
Hasselt, Limburg, Belgium, 3500
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

Responsible Party: Björn Meijers, Prof, Universitaire Ziekenhuizen Leuven Identifier: NCT00417339     History of Changes
Other Study ID Numbers: NHD002
First Posted: January 1, 2007    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Björn Meijers, Universitaire Ziekenhuizen Leuven:
dialysis adequacy
uremic retention solute

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