Mid-HDF Randomized Controlled Study on Outcome

NCT ID: NCT01693354

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2018-09-30

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HF dialysis

HF (high-flux) dialysis is standard hemodialysis treatment performed by using a high permeability dialyzer instead of a low permeability one.

Group Type: ACTIVE_COMPARATOR

HF dialysis

Intervention Type: DEVICE

Standard hemodialyzers equipped with high permeability polyphenylene/polyethersulfone membranes

Mid-dilution HDF

Mid-dilution is a newly developed hemodiafiltration therapy able to allow a simultaneous pre- and post-dilution infusion.

Group Type: EXPERIMENTAL

Mid-dilution HDF

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

HF dialysis

Standard hemodialyzers equipped with high permeability polyphenylene/polyethersulfone membranes

Intervention Type: DEVICE

Other Intervention Names

OLPUR MD 220; OLPUR MD 190; PHYLTHER HF; DIAPES HF

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Antonio Santoro

Professor Antonio Santoro MD, Chief of Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisco Maduell, MD

Role: STUDY_CHAIR

Hospital Clínic Barcelona, Spain

Vincenzo Panichi, MD, PhD

Role: STUDY_CHAIR

AUSL 12 Viareggio, Italy

Pedro Aljama, MD, PhD

Role: STUDY_CHAIR

Hospital Reina Sofia, Cordoba, Spain

Michel Jadoul, MD, PhD

Role: STUDY_CHAIR

Cliniques Universitaires Saint-Luc, Brussels, Belgium

Philippe Brunet, MD, PhD

Role: STUDY_CHAIR

Hôpital de la Conception, Marseille, France

Antonio Santoro, MD

Role: STUDY_CHAIR

AOSP Bologna, Italy

Locations

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Hôpital de la Conception

Marseille, , France

Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Hospital Clínic Barcelona

Barcelona, , Spain

Countries

Belgium; France; Italy; Spain

References

Stel VS, van de Luijtgaarden MW, Wanner C, Jager KJ; on behalf of the European Renal Registry Investigators. The 2008 ERA-EDTA Registry Annual Report-a precis. NDT Plus. 2011 Feb;4(1):1-13. doi: 10.1093/ndtplus/sfq191. Epub 2010 Nov 19.

Reference Type: BACKGROUND

PMID: 21245934 (View on PubMed)

Grooteman MP, van den Dorpel MA, Bots ML, Penne EL, van der Weerd NC, Mazairac AH, den Hoedt CH, van der Tweel I, Levesque R, Nube MJ, ter Wee PM, Blankestijn PJ; CONTRAST Investigators. Effect of online hemodiafiltration on all-cause mortality and cardiovascular outcomes. J Am Soc Nephrol. 2012 Jun;23(6):1087-96. doi: 10.1681/ASN.2011121140. Epub 2012 Apr 26.

Reference Type: BACKGROUND

PMID: 22539829 (View on PubMed)

Canaud B, Bragg-Gresham JL, Marshall MR, Desmeules S, Gillespie BW, Depner T, Klassen P, Port FK. Mortality risk for patients receiving hemodiafiltration versus hemodialysis: European results from the DOPPS. Kidney Int. 2006 Jun;69(11):2087-93. doi: 10.1038/sj.ki.5000447.

Reference Type: BACKGROUND

PMID: 16641921 (View on PubMed)

Locatelli F, Martin-Malo A, Hannedouche T, Loureiro A, Papadimitriou M, Wizemann V, Jacobson SH, Czekalski S, Ronco C, Vanholder R; Membrane Permeability Outcome (MPO) Study Group. Effect of membrane permeability on survival of hemodialysis patients. J Am Soc Nephrol. 2009 Mar;20(3):645-54. doi: 10.1681/ASN.2008060590. Epub 2008 Dec 17.

Reference Type: BACKGROUND

PMID: 19092122 (View on PubMed)

Other Identifiers

MID-INT01

Identifier Type: -

Identifier Source: org_study_id