Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT00417105
Collaborator
(none)
120
4
24
30
1.2

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: hemodialysis
  • Procedure: hemodialysis
  • Procedure: hemodialysis
  • Procedure: hemodialysis

Study Design

Study Type:
Observational
Actual Enrollment :
120 participants
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
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. removal of protein-bound retention solutes [1 dialysis session]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age > 18 years

  • Maintenance hemodialysis (> 3 months duration)

  • Informed consent

Exclusion Criteria:
  • No consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Monash Medical Centre Clayton Victoria Australia 3168
2 Geelong Hospital Geelong Victoria Australia 3220
3 Virga Jesse Ziekenhuis Hasselt Limburg Belgium 3500
4 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00417105
Other Study ID Numbers:
  • NHD001
First Posted:
Dec 29, 2006
Last Update Posted:
Mar 5, 2009
Last Verified:
Mar 1, 2009
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 5, 2009