NCT01693354

Mid-HDF Randomized Controlled Study on Outcome

Mid-dilution Hemodiafiltration International Randomized Prospective Study on Incident Patients Focused on Outcome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
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
DEVICE	HF dialysis	Standard hemodialyzers equipped with high permeability polyphenylene/polyethersulfone membranes

Timeline

• Start date: 2012-09-01
• Primary completion: 2017-09-01
• Completion: 2018-09-01
• First posted: 2012-09-26
• Last updated: 2017-01-13

Locations

4 sites across 4 countries: Belgium, France, Italy, Spain