Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00205556
Status:
COMPLETED
Last Update Posted:
2011-01-21
First Post:
2005-09-12
Brief Title:
Effect of Increased Convective Clearance by On-Line Hemodiafiltration on All Cause Mortality in Chronic Hemodialysis Patients
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Effect of Increased Convective Clearance by On-line Hemodiafiltration on All Cause and Cardiovascular Mortality in Chronic Hemodialysis Patients The Dutch Convective Transport Study CONTRAST
Status:
COMPLETED
Status Verified Date:
2011-01
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:
CONTRAST
Brief Summary:
The purpose of this study is to compare the effect of low flux hemodialysis with online hemodiafiltration on all cause mortality and a combination of cardiovascular morbidity and mortality in chronic hemodialysis patients
Detailed Description:
Today an increasing number of patients with chronic renal failure CRF is treated with on-line hemodiafiltration HDF This practice is based on the assumption that the high incidence of cardiovascular CV disease as observed in patients with CRF is at least partially related to the retention of uremic toxins in the middle and large-middle molecular MM range As HDF lowers these molecules more effectively than HD it has been suggested that this treatment improves CV outcome if compared to standard HD
Thus far no definite data on the effects of HDF on CV parameters andor clinical end-points are available Promising data include a reduction of left ventricular mass index LVMi after one year of treatment with acetate free bio-filtration AFB Furthermore relatively high survival rates were reported in a single center non-experimental study on patients who were treated with HDF if compared to the EDTA registry data on HD-treated patients Yet these data are of observational nature with the possibility of being biased by confounding by indication
As the accumulation of MMW substances has been implicated in increased oxidative stress and endothelial dysfunction a reduction of these compounds might improve these derangements In addition cardiac dysfunction atherosclerosis as measured by left ventricular mass index LVMi carotid intima media thickness CIMT and vascular stiffness as measured by pulse wave velocity PWV might be reduced during HDF as compared to low-flux HD
Therefore we propose a prospective randomized multicenter trial comparing on-line HDF with HD After a stabilization period an expected number of 700 chronic HD patients will be randomized to either HDF or low-flux HD and followed during 1-6 years Primary end points are all cause mortality and combined CV events and mortality In addition LVMi PWV CIMT and various parameters of oxidative stress acute phase reaction APR and endothelial function will be assessed and compared between treatment groups
This study will provide strong evidence on the efficacy of HDF compared to low flux HD on CV morbidity and mortality which is currently lacking but urgently needed It is highly likely that the outcome of this study will affect current clinical practice considerably in the Netherlands as well as internationally Moreover the study will point towards the mechanisms underlying the effects of HDF
The following hypotheses will be tested
1 All-cause mortality and combined CV morbidity and mortality in patients treated with on-line HDF is lower than in patients treated with standard low-flux HD
2 A reduction in MMW uremic toxins by HDF leads to an improvement of the uremic profile as measured by AGE-levels homocysteine levels oxidative stress and endothelial dysfunction if compared to standard low-flux HD
3 The improvement of the uremic profile in HDF-treated patients results in an improvement of endothelial function with a reduction in the progression of vascular injury as measured by CIMT and PWV and a reduction in LVMi if compared to standard low-flux HD
Thus far no definite data on the effects of HDF on CV parameters andor clinical end-points are available Promising data include a reduction of left ventricular mass index LVMi after one year of treatment with acetate free bio-filtration AFB Furthermore relatively high survival rates were reported in a single center non-experimental study on patients who were treated with HDF if compared to the EDTA registry data on HD-treated patients Yet these data are of observational nature with the possibility of being biased by confounding by indication
As the accumulation of MMW substances has been implicated in increased oxidative stress and endothelial dysfunction a reduction of these compounds might improve these derangements In addition cardiac dysfunction atherosclerosis as measured by left ventricular mass index LVMi carotid intima media thickness CIMT and vascular stiffness as measured by pulse wave velocity PWV might be reduced during HDF as compared to low-flux HD
Therefore we propose a prospective randomized multicenter trial comparing on-line HDF with HD After a stabilization period an expected number of 700 chronic HD patients will be randomized to either HDF or low-flux HD and followed during 1-6 years Primary end points are all cause mortality and combined CV events and mortality In addition LVMi PWV CIMT and various parameters of oxidative stress acute phase reaction APR and endothelial function will be assessed and compared between treatment groups
This study will provide strong evidence on the efficacy of HDF compared to low flux HD on CV morbidity and mortality which is currently lacking but urgently needed It is highly likely that the outcome of this study will affect current clinical practice considerably in the Netherlands as well as internationally Moreover the study will point towards the mechanisms underlying the effects of HDF
The following hypotheses will be tested
1 All-cause mortality and combined CV morbidity and mortality in patients treated with on-line HDF is lower than in patients treated with standard low-flux HD
2 A reduction in MMW uremic toxins by HDF leads to an improvement of the uremic profile as measured by AGE-levels homocysteine levels oxidative stress and endothelial dysfunction if compared to standard low-flux HD
3 The improvement of the uremic profile in HDF-treated patients results in an improvement of endothelial function with a reduction in the progression of vascular injury as measured by CIMT and PWV and a reduction in LVMi if compared to standard low-flux HD
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN38365125 | None | None | None |
| Dutch Kidney Found C 022019 | None | None | None |
| CCMO number P031089L | None | None | None |