Ignite Creation Date:
2024-05-06 @ 1:40 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01865773
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2013-05-23
Brief Title:
HFR Cartridge and Inflammation
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
Role of HFR Cartridge in the Removal of Mediators of Inflammation and P-cresol in Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HFR
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HFRinflamm | None | None | None |