No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
Primary outcome
Cardiovascular morbidity and mortality. This is a composite endpoint comprising fatal and non-fatal myocardial infarction and stroke, and vascular death (death due to vascular disease). Also all-cause mortality is considered a primary endpoint.
Secondary outcome
Changes in carotid intima media thickness (cIMT), aortic pulse wave velocity (PWV), left ventricular mass index (LVMi), interdialytic blood pressure, laboratory assessments (oxidative stress; acute phase response; lipid profile; various), quality of life, and nutritional state.
Background summary
Today, an increasing number of patients with end stage renal failure (ESRF) 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 ESRF, 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 hemodialysis (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 and/or clinical end-points are available.
As the accumulation of MM weight 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 800 chronic HD patients will be randomized to either HDF or low-flux HD for three 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 possible that the outcome of this study will affect current clinical practice considerably. Moreover, the study will point towards the mechanisms underlying the effects of HDF.
Study objective
The high incidence of cardiovascular disease in patients with end stage renal disease (ESRD) is related with the accumulation of uremic toxins in the middle and large-middle molecular weight range. As online hemodiafiltration (HDF) lowers these molecules more effectively than standard hemodialysis (HD), it is suggested that this treatment may improve cardiovascular outcome.
Intervention
Patients will be randomised between:
- online hemodiafiltration
- (continuation with) low-flux hemodialysis
P.O. Box 85500
E.L. Penne
Utrecht 3508 GA
The Netherlands
+31 (0)30 2503063
E.L.Penne@azu.nl
P.O. Box 85500
E.L. Penne
Utrecht 3508 GA
The Netherlands
+31 (0)30 2503063
E.L.Penne@azu.nl
Inclusion criteria
1. Patients treated by HD 2 or 3 times a week, for at least 2 months;
2. Patients able to understand the study procedures;
3. Patients willing to provide written informed consent.
Exclusion criteria
1. Current age younger than 18 years treatment by HDF or high flux HD in the preceding 6 months;
2. Severe incompliance life expectancy < 3 months due to non renal disease;
3. Participation to other clinical intervention trials evaluating cardiovascular outcome.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL8 |
NTR-old | NTR24 |
Other | : grant C02.2019 (Dutch Kidney Foundation) |
ISRCTN | ISRCTN38365125 |