Mid-dilution Hemodiafiltration International Randomized Prospective Study on Incident Patients Focused on Outcome
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 500
- Locations
- 4
- Primary Endpoint
- crude, all-causes mortality
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
HF dialysis
HF (high-flux) dialysis is standard hemodialysis treatment performed by using a high permeability dialyzer instead of a low permeability one.
Intervention: HF dialysis (Device)
Mid-dilution HDF
Mid-dilution is a newly developed hemodiafiltration therapy able to allow a simultaneous pre- and post-dilution infusion.
Intervention: Mid-dilution HDF (Device)
Outcomes
Primary Outcomes
crude, all-causes mortality
Time Frame: 5 years
The primary objective will be assessed by the incidence rate of fatal events
Secondary Outcomes
- Quality of life and dialysis tolerance evaluated by questionnaire(1 year)
- Micro-inflammation evaluation(1 year)
- Cardiovascular morbidity(5 years)
- Nutrition and anaemia management(1 year)
Investigators
Antonio Santoro
Professor Antonio Santoro MD, Chief of Nephrology
IRCCS Azienda Ospedaliero-Universitaria di Bologna