The Effects of Polymyxin-B Protects on Sepsis Induced Kidney Dysfunction: a Randomized Clinical Trial
Polymyxin-B Hemoperfusion Inactivates Circulating Proapoptotic Factors
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 20, 2007
CompletedFirst Posted
Study publicly available on registry
June 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
June 4, 2010
CompletedJune 8, 2010
June 1, 2007
1.2 years
June 20, 2007
March 9, 2010
June 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Not Requiring Renal Replacement Therapy (RRT)
28 days from the admission
Secondary Outcomes (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.
72 hours after randomization
Study Arms (2)
CONVENTIONAL
NO INTERVENTIONPOLYMYXIN-B
ACTIVE COMPARATORan extracorporeal LPS removal
Interventions
two hours treatment for two days
Eligibility Criteria
You may qualify if:
- Endotoxemia associated to severe sepsis
You may not qualify if:
- Age \< 18 years old
- Organ transplantation
- Hemorrhagic shock
- Thrombophilia
- Chronic renal failure
- Cardiogenic shock
- APACHE II score \> 30
- Lack of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Turin, Department of anesthesia and Intensive Care Medicine
Turin, 10126, Italy
Related Publications (1)
Cantaluppi V, Assenzio B, Pasero D, Romanazzi GM, Pacitti A, Lanfranco G, Puntorieri V, Martin EL, Mascia L, Monti G, Casella G, Segoloni GP, Camussi G, Ranieri VM. Polymyxin-B hemoperfusion inactivates circulating proapoptotic factors. Intensive Care Med. 2008 Sep;34(9):1638-45. doi: 10.1007/s00134-008-1124-6. Epub 2008 May 8.
PMID: 18463848RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- V. M. Ranieri, MD
- Organization
- University of Turin, Italy
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 20, 2007
First Posted
June 22, 2007
Study Start
May 1, 2006
Primary Completion
July 1, 2007
Study Completion
December 1, 2007
Last Updated
June 8, 2010
Results First Posted
June 4, 2010
Record last verified: 2007-06