Mid-HDF Randomized Controlled Study on Outcome

NCT01693354 | Unknown DMC

• 1 other identifier: MID-INT01
• Study Type: interventional
• Target: 500
• Locations: 4 countries
• Sites: 4

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.

Conditions

End Stage Renal Disease

Keywords

dialysis; mortality; cardiovascular stability; inflammation; quality of life

Outcome Measures

Primary Outcomes (1)

• crude, all-causes mortality

  The primary objective will be assessed by the incidence rate of fatal events

  5 years

Secondary Outcomes (4)

• Cardiovascular morbidity

  5 years

• Quality of life and dialysis tolerance evaluated by questionnaire

  1 year

• Micro-inflammation evaluation

  1 year

• Nutrition and anaemia management

  1 year

Study Arms (2)

HF dialysis

ACTIVE COMPARATOR

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

Device: HF dialysis

Mid-dilution HDF

EXPERIMENTAL

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

Device: Mid-dilution HDF

Interventions

Mid-dilution HDF 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

Also known as: OLPUR MD 220, OLPUR MD 190

Mid-dilution HDF

HF dialysis DEVICE

Standard hemodialyzers equipped with high permeability polyphenylene/polyethersulfone membranes

Also known as: PHYLTHER HF, DIAPES HF

HF dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• On a thrice/week RRT for at least 3 months
• Dialysis vintage \> 3 months
• Signed informed consent
• Blood flow \> 300 mL/min

You may not qualify if:

• 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
• Pregnancy

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (4)

Cliniques Universitaires Saint-Luc

Brussels, 3000, Belgium

Location

Hôpital de la Conception

Marseille, 13385, France

Location

Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

Hospital Clínic Barcelona

Barcelona, 08036, Spain

Location

Related Publications (4)

• 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.

  PMID: 21245934 BACKGROUND

• 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.

  PMID: 22539829 BACKGROUND

• 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.

  PMID: 16641921 BACKGROUND

• 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.

  PMID: 19092122 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Antonio Santoro MD, Chief of Nephrology

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 26, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: January 13, 2017

Record last verified: 2017-01

Locations

BE (1); IT (1); FR (1); ES (1)