Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis
|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.|
|ClinicalTrials.gov Identifier: NCT00417105|
Recruitment Status : Completed
First Posted : December 29, 2006
Last Update Posted : March 5, 2009
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|
|End Stage Renal Disease||Procedure: hemodialysis|
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|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 :||December 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
hemodialysis twice weekly 4 hours
group 1: twice weekly, four hours
nocturnal dialysis twice weekly 8 hours
group 2: twice weekly, eight hours
nocturnal hemodialysis, 8 hours every other night
group 3: every other day, eight hours
nocturnal hemodialysis, 8 hours, six times per week
group 4: six days a week, eight hours
- removal of protein-bound retention solutes [ Time Frame: 1 dialysis session ]
Biospecimen Retention: Samples Without DNA
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 ClinicalTrials.gov identifier (NCT number): NCT00417105
|Monash Medical Centre|
|Clayton, Victoria, Australia, 3168|
|Geelong, Victoria, Australia, 3220|
|Virga Jesse Ziekenhuis|
|Hasselt, Limburg, Belgium, 3500|
|Universitaire Ziekenhuizen Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|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|