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HFR Cartridge and Inflammation (HFR)

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ClinicalTrials.gov Identifier: NCT01865773
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
Eleonora Riccio, Federico II University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Inflammatory Status P-cresol Procedure: HFR dialysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Role of HFR Cartridge in the Removal of Mediators of Inflammation and P-cresol in Hemodialysis Patients
Study Start Date : January 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: HFR
We selected 8 inflamed chronic HD patients, which underwent a single 240 minutes HFR session
Procedure: HFR dialysis
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.
Other Name: hmodiafiltration with on line reinfusion of ultrafiltrate




Primary Outcome Measures :
  1. IL-6 removal by a single session of HFR-Supra [ Time Frame: The evaluation will be performed for the duration of a single HFR session of 240 minutes ]
    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.

  2. P-cresol removal by a single HFR session [ Time Frame: The evaluation will be performed for the duration of a single HFR session of 240 minutes ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HD patients undergoing three weekly haemodialysis > 1 year

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865773


Locations
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Italy
federico II university, department of nephrology
Naples, Italy, 80129
Sponsors and Collaborators
Federico II University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eleonora Riccio, MD, Federico II University
ClinicalTrials.gov Identifier: NCT01865773     History of Changes
Other Study ID Numbers: HFR13
HFRinflamm
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes