Mid-HDF Randomized Controlled Study on Outcome (MILESTONE)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Mid-dilution Hemodiafiltration International Randomized Prospective Study on Incident Patients Focused on Outcome|
- crude, all-causes mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]The primary objective will be assessed by the incidence rate of fatal events
- Cardiovascular morbidity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
It will be assessed by taking into consideration:
- Results of the SF-36 questionnaire given to the patients
- Micro-inflammation evaluation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Active Comparator: HF dialysis
HF (high-flux) dialysis is standard hemodialysis treatment performed by using a high permeability dialyzer instead of a low permeability one.
Device: HF dialysis
Standard hemodialyzers equipped with high permeability polyphenylene/polyethersulfone membranes
Experimental: Mid-dilution HDF
Mid-dilution is a newly developed hemodiafiltration therapy able to allow a simultaneous pre- and post-dilution infusion.
Device: Mid-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
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 . 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 , 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 .
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693354
|Contact: Antonio Santoro, MD||(+39)firstname.lastname@example.org|
|Cliniques Universitaires Saint-Luc||Recruiting|
|Brussels, Belgium, 3000|
|Contact: Michel Jadoul, MD, PhD (+32) 02 764 18 55 email@example.com|
|Principal Investigator: Michel Jadoul, MD, PhD|
|Hôpital de la Conception||Recruiting|
|Marseille, France, 13385|
|Contact: Philippe Brunet, MD, PhD (+33) 4 91 383042 firstname.lastname@example.org|
|Principal Investigator: Philippe Brunet, MD, PhD|
|Azienda Ospedaliero-Universitaria di Bologna||Recruiting|
|Bologna, Italy, 40138|
|Contact: Elena Mancini, MD (+39)0516362431 email@example.com|
|Sub-Investigator: Elena Mancini, MD|
|Principal Investigator: Antonio Santoro, MD|
|Hospital Clínic Barcelona||Recruiting|
|Barcelona, Spain, 08036|
|Contact: Francisco Maduell, MD (+34) 93 227 93 46 firstname.lastname@example.org|
|Principal Investigator: Francisco Maduell, MD|
|Study Chair:||Francisco Maduell, MD||Hospital Clínic Barcelona, Spain|
|Study Chair:||Vincenzo Panichi, MD, PhD||AUSL 12 Viareggio, Italy|
|Study Chair:||Pedro Aljama, MD, PhD||Hospital Reina Sofia, Cordoba, Spain|
|Study Chair:||Michel Jadoul, MD, PhD||Cliniques Universitaires Saint-Luc, Brussels, Belgium|
|Study Chair:||Philippe Brunet, MD, PhD||Hôpital de la Conception, Marseille, France|
|Study Chair:||Antonio Santoro, MD||AOSP Bologna, Italy|