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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00490477
Recruitment Status : Completed
First Posted : June 22, 2007
Results First Posted : June 4, 2010
Last Update Posted : June 8, 2010
Information provided by:
University of Turin, Italy

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Polymyxin-B Hemoperfusion Inactivates Circulating Proapoptotic Factors
Study Start Date : May 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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 ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
Responsible Party: V. M. Ranieri, MD, University of Turin Identifier: NCT00490477     History of Changes
Other Study ID Numbers: N-257
First Posted: June 22, 2007    Key Record Dates
Results First Posted: June 4, 2010
Last Update Posted: June 8, 2010
Last Verified: June 2007

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