Mid-HDF Randomized Controlled Study on Outcome (MILESTONE)
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|ClinicalTrials.gov Identifier: NCT01693354|
Recruitment Status : Unknown
Verified January 2017 by Antonio Santoro, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
Recruitment status was: Active, not recruiting
First Posted : September 26, 2012
Last Update Posted : January 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Device: Mid-dilution HDF Device: HF dialysis||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mid-dilution Hemodiafiltration International Randomized Prospective Study on Incident Patients Focused on Outcome|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2018|
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
- crude, all-causes mortality [ Time Frame: 5 years ]The primary objective will be assessed by the incidence rate of fatal events
- Cardiovascular morbidity [ Time Frame: 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 [ Time Frame: 1 year ]
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 ]
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 ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693354
|Cliniques Universitaires Saint-Luc|
|Brussels, Belgium, 3000|
|Hôpital de la Conception|
|Marseille, France, 13385|
|Azienda Ospedaliero-Universitaria di Bologna|
|Bologna, Italy, 40138|
|Hospital Clínic Barcelona|
|Barcelona, Spain, 08036|
|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|