The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction: a Randomized Clinical Trial
Information source: University of Turin, Italy
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gram-Negative Bacterial Infections; Sepsis
Intervention: Polymyxin -B fiber hemoperfusion system (Device)
Phase: Phase 3
Status: Completed
Sponsored by: University of Turin, Italy Official(s) and/or principal investigator(s): marco ranieri, MD, Study Director, Affiliation: University of Turin, Department of Anesthesia and Intensive Care Medicine marco ranieri, MD, Principal Investigator, Affiliation: University of Turin, Department of Anesthesia and Intensive Care Medicine
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.
Clinical Details
Official title: Polymyxin-B Hemoperfusion Inactivates Circulating Proapoptotic Factors
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Number of Participants Not Requiring Renal Replacement Therapy (RRT)
Secondary outcome: The Reduction of the Number of Apoptotic Cells, Stimulated With Plasma Derives From Septic Patients With Gram Negative Infection, Treated With PMX-B Hemoperfusion, on Immortalized Tubular and Glomerular Cell Cultures.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Endotoxemia associated to severe sepsis
Exclusion Criteria:
- Age < 18 years old
- Organ transplantation
- Hemorrhagic shock
- Thrombophilia
- Chronic renal failure
- Cardiogenic shock
- APACHE II score > 30
- Lack of consent
Locations and Contacts
University of Turin, Department of anesthesia and Intensive Care Medicine, Turin 10126, Italy
Additional Information
Starting date: May 2006
Last updated: June 4, 2010
|