Sepsis Clinical Trial
Official title:
Polymyxin-B Hemoperfusion Inactivates Circulating Proapoptotic Factors
Aim of the study is to verify whether Polymyxin-B hemoperfusion protects from renal dysfunction in patients with severe sepsis from gram negative infection.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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