HFR Cartridge and Inflammation (HFR)

Role of HFR Cartridge in the Removal of Mediators of Inflammation and P-cresol in Hemodialysis Patients

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Status; P-cresol
• Intervention / Treatment: Procedure: HFR dialysis

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80129
    • federico II university, department of nephrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HD patients undergoing three weekly haemodialysis > 1 year

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: hmodiafiltration with on line reinfusion of ultrafiltrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: May 23, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Estimate): May 31, 2013
• Last Update Submitted That Met QC Criteria: May 28, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: HFR13; HFRinflamm