Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490477
Status:
COMPLETED
Last Update Posted:
2010-06-08
First Post:
2007-06-20
Brief Title:
The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction a Randomized Clinical Trial
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
Polymyxin-B Hemoperfusion Inactivates Circulating Proapoptotic Factors
Status:
COMPLETED
Status Verified Date:
2007-06
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:
None
Brief Summary:
Aim of the study is to verify whether Polymyxin-B hemoperfusion protects from renal dysfunction in patients with severe sepsis from gram negative infection
Detailed Description:
Acute renal failure ARF is a frequent complication in sepsis in nearly to 50 of the cases and the mortality rate is higher compare to patients with ARF alone 70 vs 45 Clinical and experimental studies demonstrated the key role of apoptosis or programmed cell death in the induction of tubular and glomerular injury in the course of sepsis Indeed it has been shown that inflammatory cytokines and lipopolysaccharide LPS cause renal tubular cell apoptosis via Fas- and caspase-mediated pathways In addition LPS is able to alter the normal expression pattern of sodium urea and glucose renal transporters and to modulate tubular polarity by changing the expression of tight junction proteins with consequent back-leakage of tubular fluid in the interstitial spaces and enhancement of the inflammatory process Therefore a novel extracorporeal therapy to remove circulating LPS using the Polymyxin-B fiber PMX-B cartridge was developed The PMX-B cartridge is an extracorporeal hemoperfusion device and consists of a polystyrene-based fibrous adsorbent on which the polymyxin B antibiotic is covalently immobilized as a ligand to adsorb endotoxin
Aim of this study is to verify whether the removal of LPS using the PMX-B hemoperfusion system protects from acute renal failure reduces the need for Renal Replacement Therapy RRT and consequently improves the outcome in severe sepsis from gram negative infection
Aim of this study is to verify whether the removal of LPS using the PMX-B hemoperfusion system protects from acute renal failure reduces the need for Renal Replacement Therapy RRT and consequently improves the outcome in severe sepsis from gram negative infection
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