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

ESRD Clinical Trial

— HEPHAESTUS  

Official title:

tHe Effects of Postdilution Online Hemodiafiltration With AcEtate-free Citrate dialySis Fluid on Inflammation Markers in TUscan Prevalent Hemodialysis patientS: HEPHAESTUS Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863016
• Other study ID #: HEPHAESTUS_020713
• Status: Completed
• Start date: July 2016
• Est. completion date: April 2017

Study information

• Verified date: December 2020
• Source: Ospedale Santa Maria Annunziata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The primary objective of this study was to evaluate if a hemodiafiltration with concentrated citrate (Cit-HDF) in 3 months can reduce the inflammation markers, evaluated by a Predialytic value of Beta2-microglobulin (B2m), CRP and IL6 compared to traditional concentrated acetic acid (Ac-HDF).

The secondary objectives of this study are to evaluate if Cit-HDF, compared to Ac-HDF, can have an effect in a period of 3 months on the following aspects:

• the change weekly pre-dialysis values of other markers of oxidative stress (TAC, NF-kB);

• the technical parameters of HDF treatment, such as convective volumes, and blood pressure in the circuit in the filter (TMP, pressure pre-filter);

• the cardiovascular stability through blood pressure and heart rate before and after dialysis (SBP, DBP, HR) and number of intradialytic hypotension;

• the parameters of safety as the variation of the values of the mobility Predialytic bone (PTH, alkaline phosphatase, fetuin-A), the variation of the values intradialytic biochemical impacted by citrate (total and ionized calcium, bicarbonate) and clotting time (aPTT);

• the variation of calcifications observed by:

• the expression of molecules that express the ability of calcification of muscle cells and endothelial cells in culture with plasma taken at the beginning of treatment

• a measure of carotid intimal thickness and pulse vawe velocity by Eco Color Doppler (optional);

• dialysis efficiency by varying pre-and post-dialysis (RR%) and Clearance average molecular weight solutes with small and medium (Phosphorus, Beta2 Micro, Myoglobin) and indices of dialysis adequacy of small molecules such as EKT / V based on the dialysance ion formula Watson (calculated automatically by the monitor to dialysis);

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

. 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%.

Exclusion Criteria:

• Life expectancy <3 months.

• With residual renal function> 500 ml / day.

• Vascular access with CVC

Related Conditions & MeSH terms

• ESRD
• Inflammation

Intervention

Device:
• SelectBag One
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.

Locations

Country	Name	City	State
Italy	Ospedale Santa Maria Annunziata	Firenze	Fi
Italy	Ospedale Versilia	Lido Di Camaiore	Lucca
Italy	Ospedale Campo di Marte	Lucca

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Santa Maria Annunziata

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Maduell F, Moreso F, Pons M, Ramos R, Mora-Macià 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. Erratum in: J Am Soc Nephrol. 2014 May;25(5):1130. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation	Value of IL-6	3 months
Secondary	Dialytic dose	convective exchange volumes	3 months