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The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction: a Randomized Clinical Trial

This study has been completed.
Information provided by:
University of Turin, Italy Identifier:
First received: June 20, 2007
Last updated: June 4, 2010
Last verified: June 2007
Aim of the study is to verify whether Polymyxin-B hemoperfusion protects from renal dysfunction in patients with severe sepsis from gram negative infection.

Condition Intervention Phase
Gram-Negative Bacterial Infections Sepsis Device: Polymyxin -B fiber hemoperfusion system Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Polymyxin-B Hemoperfusion Inactivates Circulating Proapoptotic Factors

Resource links provided by NLM:

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • Number of Participants Not Requiring Renal Replacement Therapy (RRT) [ Time Frame: 28 days from the admission ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 72 hours after randomization ]

Enrollment: 16
Study Start Date: May 2006
Study Completion Date: December 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: CONVENTIONAL
Active Comparator: POLYMYXIN-B
an extracorporeal LPS removal
Device: Polymyxin -B fiber hemoperfusion system
two hours treatment for two days
Other Name: PMX-B

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00490477

University of Turin, Department of anesthesia and Intensive Care Medicine
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Study Director: marco ranieri, MD University of Turin, Department of Anesthesia and Intensive Care Medicine
Principal Investigator: marco ranieri, MD University of Turin, Department of Anesthesia and Intensive Care Medicine
  More Information

Responsible Party: V. M. Ranieri, MD, University of Turin Identifier: NCT00490477     History of Changes
Other Study ID Numbers: N-257
Study First Received: June 20, 2007
Results First Received: March 9, 2010
Last Updated: June 4, 2010

Keywords provided by University of Turin, Italy:
acute renal failure
tubular apoptosis
Polymyxin-B fiber
Severe sepsis from gram negative infection

Additional relevant MeSH terms:
Bacterial Infections
Gram-Negative Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Polymyxin B
Anti-Bacterial Agents
Anti-Infective Agents processed this record on September 19, 2017