Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417339
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2006-12-28
Brief Title:
Protein-bound Uremic Retention Solutes and Long Nocturnal Hemodialysis a Longitudinal Analysis
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
A Multicentric Observational Trial on Protein Bound Uremic Toxins in Nocturnal Hemodialysis
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study on intradialytic kinetics of protein-bound uremic retention solutes during long nocturnal 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 causes 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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None