Effects of Postdilution Online Hemodiafiltration With AcEtate-free Citrate dialySis Fluid on Inflammation Markers
NCT ID: NCT02863016
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
66 participants
OBSERVATIONAL
2016-07-31
2017-04-30
Brief Summary
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Detailed Description
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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);
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
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.
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)
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* With residual renal function\> 500 ml / day.
* Vascular access with CVC
18 Years
ALL
No
Sponsors
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Ospedale Santa Maria Annunziata
OTHER
Responsible Party
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Francesco Pizzarelli
Principal Investigator
Principal Investigators
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Francesco Pizzarelli, Dr
Role: PRINCIPAL_INVESTIGATOR
Ospedale Santa Maria Annunziata_ Firenze (Italy)
Locations
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Ospedale Santa Maria Annunziata
Florence, Fi, Italy
Ospedale Versilia
Lido di Camaiore, Lucca, Italy
Ospedale Campo di Marte
Lucca, , Italy
Countries
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References
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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.
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
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.
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.
Other Identifiers
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HEPHAESTUS_020713
Identifier Type: -
Identifier Source: org_study_id