- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00417105
Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis
A Multicentric Observational Study on the Removal of Protein-Bound Uremic Retention Solutes in Nocturnal Hemodialysis: A Cross-Sectional Analysis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Medical Centre
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Geelong, Victoria, Australia, 3220
- Geelong Hospital
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-
-
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Limburg
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Hasselt, Limburg, Belgium, 3500
- Virga Jesse Ziekenhuis
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- Universitaire Ziekenhuizen Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years
- Maintenance hemodialysis (> 3 months duration)
- Informed consent
Exclusion Criteria:
- No consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
hemodialysis twice weekly 4 hours
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group 1: twice weekly, four hours
group 2: twice weekly, eight hours
group 3: every other day, eight hours
group 4: six days a week, eight hours
|
|
2
nocturnal dialysis twice weekly 8 hours
|
group 1: twice weekly, four hours
group 2: twice weekly, eight hours
group 3: every other day, eight hours
group 4: six days a week, eight hours
|
|
3
nocturnal hemodialysis, 8 hours every other night
|
group 1: twice weekly, four hours
group 2: twice weekly, eight hours
group 3: every other day, eight hours
group 4: six days a week, eight hours
|
|
4
nocturnal hemodialysis, 8 hours, six times per week
|
group 1: twice weekly, four hours
group 2: twice weekly, eight hours
group 3: every other day, eight hours
group 4: six days a week, eight hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
removal of protein-bound retention solutes
Time Frame: 1 dialysis session
|
1 dialysis session
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tom Dejagere, MD, Virga Jesse Ziekenhuis
- Principal Investigator: Nigel Toussaint, MD, Geelong Hospital
Publications and helpful links
General Publications
- Bammens B, Evenepoel P, Keuleers H, Verbeke K, Vanrenterghem Y. Free serum concentrations of the protein-bound retention solute p-cresol predict mortality in hemodialysis patients. Kidney Int. 2006 Mar;69(6):1081-7. doi: 10.1038/sj.ki.5000115.
- Fagugli RM, De Smet R, Buoncristiani U, Lameire N, Vanholder R. Behavior of non-protein-bound and protein-bound uremic solutes during daily hemodialysis. Am J Kidney Dis. 2002 Aug;40(2):339-47. doi: 10.1053/ajkd.2002.34518.
- Pierratos A. Daily nocturnal home hemodialysis. Kidney Int. 2004 May;65(5):1975-86. doi: 10.1111/j.1523-1755.2004.00603.x. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHD001
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