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Sponsored by: |
Universitaire Ziekenhuizen Leuven |
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Information provided by: | Universitaire Ziekenhuizen Leuven |
ClinicalTrials.gov Identifier: | NCT00417105 |
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 |
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End Stage Renal Disease |
Procedure: hemodialysis |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | A Multicentric Observational Study on the Removal of Protein-Bound Uremic Retention Solutes in Nocturnal Hemodialysis: A Cross-Sectional Analysis |
serum, urine, dialysate
Estimated Enrollment: | 150 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
hemodialysis twice weekly 4 hours
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Procedure: hemodialysis
group 1: twice weekly, four hours
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2
nocturnal dialysis twice weekly 8 hours
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Procedure: hemodialysis
group 2: twice weekly, eight hours
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3
nocturnal hemodialysis, 8 hours every other night
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Procedure: hemodialysis
group 3: every other day, eight hours
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4
nocturnal hemodialysis, 8 hours, six times per week
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Procedure: hemodialysis
group 4: six days a week, eight hours
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Maintenance hemodialysis patients
Inclusion Criteria:
Exclusion Criteria:
Contact: Björn KI Meijers, MD | 00 32 (0)16 342352 | bjorn.meijers@uz.kuleuven.ac.be |
Contact: Pieter Evenepoel, MD, PhD | 00 32 (0)16 344580 | pieter.evenepoel@uz.kuleuven.ac.be |
Australia, Victoria | |
Monash Medical Centre | Recruiting |
Clayton, Victoria, Australia, 3168 | |
Contact: Nigel Toussaint, MD +61 3 9594 3529 nigel.toussaint@med.monash.edu.au | |
Contact: Peter Kerr, MD + 61 3 9594 3529 peter.kerr@med.monash.edu.au | |
Principal Investigator: Nigel Toussaint, MD | |
Principal Investigator: Peter Kerr, MD | |
Sub-Investigator: Kevan Polkinhorne | |
Geelong Hospital | Recruiting |
Geelong, Victoria, Australia, 3220 | |
Contact: John Agar, MD +61 3 5226 7499 johna@barwonhealth.org.au | |
Principal Investigator: John Agar, MD | |
Belgium, Limburg | |
Virga Jesse Ziekenhuis | Recruiting |
Hasselt, Limburg, Belgium, 3500 | |
Contact: Tom Dejagere, MD 00 32 (0)11 308111 tom.dejagere@virgajesse.be | |
Principal Investigator: Tom Dejagere, MD | |
Belgium, Vlaams-Brabant | |
Universitaire Ziekenhuizen Leuven | Recruiting |
Leuven, Vlaams-Brabant, Belgium, 3000 | |
Contact: Björn KI Meijers, MD 00 32 (0)16 342352 bjorn.meijers@uz.kuleuven.ac.be | |
Principal Investigator: Björn KI Meijers, MD |
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: | University Hospitals Leuven ( Pieter Evenepoel ) |
Study ID Numbers: | NHD001 |
Study First Received: | December 28, 2006 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00417105 |
Health Authority: | Belgium: Institutional Review Board |
hemodialysis, dialysis adequacy, chronic kidney disease |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Kidney Diseases Urinary Retention Kidney Failure |