Effects of Postdilution Online Hemodiafiltration With AcEtate-free Citrate dialySis Fluid on Inflammation Markers

NCT02863016 | Completed

• 1 other identifier: HEPHAESTUS_020713
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this study was to evaluate the effect and timing of action on the inflammatory state of a acetate-free containing citrate concentrate (Cit-, 1 mM Citrate) in online postidultion HDF with high volumes compared to traditional concentrated (Ac-, 3 mM of acetate ) in the medium term. In addition, the study will evaluate other parameters of efficiency dialysis, cardiovascular stability, the safety of the concentrate with regard to bone metabolism and vessel calcification in the medium term.

Conditions

ESRD

Keywords

dialysis; hemodiafiltration

Outcome Measures

Primary Outcomes (1)

• Inflammation

  Value of IL-6

  3 months

Secondary Outcomes (1)

• Dialytic dose

  3 months

Study Arms (2)

Concentrate SelectBag One

Each patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution: first of all concentrate SelectBag One (with 3 mM of acetic acid and 0 mM of citrate)

Device: SelectBag One

Concentrate SelectBag Citrate

Each patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution, then with SelectBag Citrate (with 0 mM of acetic acid and 1 mM of citric acid)

Device: SelectBag One

Interventions

SelectBag One DEVICE

Each patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution with two kind of concentrates: acetic acid (Ac-HDF) and acetate-free citrate containing one (HDF-Cit ). For each of the sessions will be used online HDF postdilution with TMP biofeedback (UltraControl) and Filter high permeability.

Also known as: SelectBag Citrate

Concentrate SelectBag Citrate; Concentrate SelectBag One

Eligibility Criteria

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

Study Population

* Patients clinically stable. * age\> 18. * HDF in renal replacement therapy for more than 1 month. * good functionality of the vascular blood flow that allows real at least 250 ml / min. and recirculation below 10%.

You may qualify if:

• Patients clinically stable.
• age\> 18.
• HDF in renal replacement therapy for more than 1 month.
• good functionality of the vascular blood flow that allows real at least 250 ml / min. and recirculation below 10%.

You may not qualify if:

• Life expectancy \<3 months.
• With residual renal function\> 500 ml / day.
• Vascular access with CVC

Sponsors & Collaborators

• Ospedale Santa Maria Annunziata: lead

Study Sites (3)

Ospedale Santa Maria Annunziata

Florence, Fi, Italy

Location

Ospedale Versilia

Lido di Camaiore, Lucca, Italy

Location

Ospedale Campo di Marte

Lucca, Italy

Location

Related Publications (4)

• Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Carreras J, Soler J, Torres F, Campistol JM, Martinez-Castelao A; ESHOL Study Group. High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients. J Am Soc Nephrol. 2013 Feb;24(3):487-97. doi: 10.1681/ASN.2012080875. Epub 2013 Feb 14.

  PMID: 23411788 BACKGROUND

• Panichi V., Bernabini G., Fanelli R., Rosati A., Pizzarelli F. Emodiafiltrazione (HDF) on line in post-diluizione con un nuovo concentrato acido a base di citrato: risultati di uno studio pilota multicentrico. Atti Convegno SIN, Genova, 2011

  BACKGROUND

• Matsuyama K, Tomo T, Kadota J. Acetate-free blood purification can impact improved nutritional status in hemodialysis patients. J Artif Organs. 2011 Jun;14(2):112-9. doi: 10.1007/s10047-010-0551-7. Epub 2011 Feb 19.

  PMID: 21336818 BACKGROUND

• Pizzarelli F, Cantaluppi V, Panichi V, Toccafondi A, Ferro G, Farruggio S, Grossini E, Dattolo PC, Miniello V, Migliori M, Grimaldi C, Casani A, Borzumati M, Cusinato S, Capitanini A, Quercia A, Filiberti O, Dani L; Hephaestus study group. Citrate high volume on-line hemodiafiltration modulates serum Interleukin-6 and Klotho levels: the multicenter randomized controlled study "Hephaestus". J Nephrol. 2021 Oct;34(5):1701-1710. doi: 10.1007/s40620-020-00943-6. Epub 2021 Feb 9.

  PMID: 33559851 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

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

• Francesco Pizzarelli, Dr

  Ospedale Santa Maria Annunziata_ Firenze (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 11, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: April 1, 2017
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)