HFR Cartridge and Inflammation

NCT01865773 | Completed

• 2 other identifiers: HFR13HFRinflamm
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Status; P-cresol

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

HFR

EXPERIMENTAL

We selected 8 inflamed chronic HD patients, which underwent a single 240 minutes HFR session

Procedure: HFR dialysis

Interventions

HFR dialysis PROCEDURE

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.

Also known as: hmodiafiltration with on line reinfusion of ultrafiltrate

HFR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HD patients undergoing three weekly haemodialysis \> 1 year

You may not qualify if:

• none

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

federico II university, department of nephrology

Naples, Naples, 80129, Italy

Location

Related Publications (1)

• 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.

  PMID: 24755610 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 31, 2013
• Study Start: January 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 31, 2013

Record last verified: 2013-04

Locations

IT (1)