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

This study has been completed.
Sponsor:
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00490477
First received: June 20, 2007
Last updated: June 4, 2010
Last verified: June 2007
History of Changes
Results First Received: March 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Gram-Negative Bacterial Infections
Sepsis
Intervention: Device: Polymyxin -B fiber hemoperfusion system

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Conventional Treatment (CONV) patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
Polymyxin-B Hemoperfusion Treatment (PMX-B) patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS

Participant Flow:   Overall Study
    Conventional Treatment (CONV)     Polymyxin-B Hemoperfusion Treatment (PMX-B)  
STARTED     8     8  
COMPLETED     8     8  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Conventional Treatment (CONV) patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
Polymyxin-B Hemoperfusion Treatment (PMX-B) patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
Total Total of all reporting groups

Baseline Measures
    Conventional Treatment (CONV)     Polymyxin-B Hemoperfusion Treatment (PMX-B)     Total  
Number of Participants  
[units: participants]
 		  8     8     16  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     6     4     10  
>=65 years     2     4     6  
Age  
[units: years]
Mean ± Standard Deviation 		  59  ± 13     61  ± 10     60  ± 11  
Gender  
[units: participants]
 		     
Female     2     2     4  
Male     6     6     12  
Region of Enrollment  
[units: participants]
 		     
Italy     8     8     16  



  Outcome Measures

1.  Primary:   Number of Participants Not Requiring Renal Replacement Therapy (RRT)   [ Time Frame: 28 days from the admission ]
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2.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   04/2007   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: V. M. Ranieri, MD
Organization: University of Turin, Italy
phone: 00390116334001
e-mail: marco.ranieri@unito.it


Publications of Results:


Responsible Party: V. M. Ranieri, MD, University of Turin
ClinicalTrials.gov 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
Health Authority: Italy: Ministry of Health