NCT01865773|Completed
HFR Cartridge and Inflammation
HFR
Role of HFR Cartridge in the Removal of Mediators of Inflammation and P-cresol in Hemodialysis Patients
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HFR
Role of HFR Cartridge in the Removal of Mediators of Inflammation and P-cresol in Hemodialysis Patients
Sponsor study identifier
Secondary identifiers
interventional
8
1 country
1
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2012
Actual (reported)Study Completion
September 2012
Actual (reported)A major limitation of standard hemodialysis is that it does not clear the plasma from interleukin-6 (IL-6) and p-cresol, two uremic toxins responsible for the high cardiovascular risk in end stage renal disease (ESRD). In the present study, we evaluated whether these compounds are removed by HFR-Supra, a double-chamber hemodiafiltration system in which the ultrafiltrate (UF) returns to the patient after its regeneration through a resin cartridge. We selected 8 inflamed chronic hemodialysis (HD) patients, which underwent a single 240 minutes HFR session. We studied the change in both IL-6 and p-cresol circulating levels, by comparing pre- and post-HFR serum concentrations. In addition, we compared Il-6 and p-cresol levels in the UF entering (UFin) and exiting (UFout) from the cartridge, either at the start or at the end of the HFR session. The proinflammatory activity of UFin and UFout was determined by evaluating the changes that they induced in IL-6 messenger ribonucleic acid (mRNA) expression and release in peripheral blood mononuclear cells (PBMC) collected from 8 healthy volunteers and cultured in vitro for 24 hr.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
April 2012
Actual (reported)September 2012
Actual (reported)May 23, 2013
Actual (reported)May 31, 2013
Actual (reported)IL-6 removal by a single session of HFR-Supra
We studied the change in IL-6 circulating levels, by comparing pre- and post-HFR serum concentrations. In addition, we compared IL-6 levels in the UF entering (UFin) and exiting (UFout) from the cartridge, either at the start or at the end of the HFR session. The proinflammatory activity of UFin and UFout was determined by evaluating the changes that they induced in IL-6 mRNA expression and release in peripheral blood mononuclear cells (PBMC) collected from 8 healthy volunteers and cultured in vitro for 24 hr.
The evaluation will be performed for the duration of a single HFR session of 240 minutes
P-cresol removal by a single HFR session
We studied the change in p-cresol circulating levels, by comparing pre- and post-HFR serum concentrations. In addition, we compared p-cresol levels in the UF entering (UFin) and exiting (UFout) from the cartridge, either at the start or at the end of the HFR session.
The evaluation will be performed for the duration of a single HFR session of 240 minutes
We selected 8 inflamed chronic HD patients, which underwent a single 240 minutes HFR session
HFR is a dialysis technique that combines the processes of diffusion, convection and adsorption. In this double chamber hemodiafiltration system, the ultrafiltrate is reinfused after its passage (and opportune modification) through a resin cartridge.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
federico II university, department of nephrology
Naples, Naples, 80129, Italy
Riccio E, Cataldi M, Minco M, Argentino G, Russo R, Brancaccio S, Memoli A, Grumetto L, Postiglione L, Guida B, Memoli B. Evidence that p-cresol and IL-6 are adsorbed by the HFR cartridge: towards a new strategy to decrease systemic inflammation in dialyzed patients? PLoS One. 2014 Apr 22;9(4):e95811. doi: 10.1371/journal.pone.0095811. eCollection 2014.
8 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2013
First Posted
May 31, 2013
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
April 2012
Actual (reported)Study Completion
September 2012
Actual (reported)Last Updated
May 31, 2013
Record last verified: 2013-04
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Source: ClinicalTrials.gov.
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