End Stage Renal Disease
Conditions
Keywords
dialysis, mortality, cardiovascular stability, inflammation, quality of life
Brief summary
The purpose of this study is to determine whether mid-dilution hemodiafiltration is effective in the reduction of the crude mortality risk in patients who have been undergoing renal replacement treatment for less than 1 year. Patients will be randomized since the beginning of the study in two groups: standard HF dialysis and mid-dilution HDF.
Detailed description
It is a matter of fact that in the last decades the Chronic Kidney Disease (CKD) population has widely changed. In Italy, for example, more than 50% of the incident dialysis patients are more than 70 year old, with diabetic and hypertension being the major underlying diseases; moreover a great percentage of the patients starts dialysis with a burden of at least 1-2 comorbidities \[1\]. Online hemodiafiltration (online HDF) has been recently associated with better patient survival in comparison with standard hemodialysis in two large trials \[2,3\]; the overall relative risk of mortality was found to be approximately 33% lower in patients treated with online HDF \[2,3\]. These impressive results were not obtained anyway on the whole population, but in a sub-group analysis. A strong correlation was found between the total convective volume obtained and the mortality risk reduction; HDF was found to be significantly better than standard hemodialysis when a total convective volume of 19-22 L/session (in 4 hours sessions of post-dilution HDF) was achieved. These results support the importance of the adequate convective dose concept in order to improve the patient outcomes especially in frail patients, as recently demonstrated by a large randomised control trial, the MPO study \[4\], comparing High Flux versus Low Flux dialysis in patients with plasma albumin levels equal to or less than 4 gr/dl ( as a marker of patient comorbidities) and, in a post hoc analysis, in diabetic patients \[4\]. Mid-dilution HDF is a variant of classical HDF combining simultaneous pre- and post.-dilution in order to maximise middle and large solutes removal. The MILESTONE study would aim to fully demonstrate for mid-dilution HDF the significant mortality risk reduction observed in the recent mentioned studies.
Interventions
DEVICEMid-dilution HDF
Mid-dilution HDF is a special, newly developed variant of online HDF which is characterized by a dedicated high-flux hemodialyzer named OLPUR MD able to support simultaneous pre- and post-dilution
DEVICEHF dialysis
Standard hemodialyzers equipped with high permeability polyphenylene/polyethersulfone membranes
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* On a thrice/week RRT for at least 3 months * Dialysis vintage \> 3 months * Signed informed consent * Blood flow \> 300 mL/min
Exclusion criteria
* On waiting list for living-donor transplant * Residual diuresis \> 500 mL/day * Inability, as judget by the investigator, to follow or understand the protocol instructions * Active neoplastic disease * Single needle treatment * Patients with expectancy life lower than 6 months * Inclusion to other studies * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| crude, all-causes mortality | 5 years | The primary objective will be assessed by the incidence rate of fatal events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular morbidity | 5 years | It will be assessed by taking into consideration: * Number of hospital admissions related to non fatal major CV events * Length of stay during hospitalization |
| Quality of life and dialysis tolerance evaluated by questionnaire | 1 year | It will be assessed by taking into consideration: \- Results of the SF-36 questionnaire given to the patients |
| Micro-inflammation evaluation | 1 year | It will be assessed by measuring the pre-dialysis serum levels of: IL-6 CR Myoglobin RbP p-cresylsulfate beta2-microglobulin. The hospitals' laboratories will be in charge for the sample collection and analysis |
| Nutrition and anaemia management | 1 year | It will be assessed by taking in consideration the pre-dialysis serum levels of: Hb albumin iron. ESAs and iron supplementation will be as well noted in apposite CRF. |
Countries
Belgium, France, Italy, Spain
Outcome results
None listed