Status:
COMPLETED
Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis
Lead Sponsor:
St. Bortolo Hospital
Conditions:
Gram-Negative Bacterial Infections
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This clinical study designed as a prospective, open labelled, multi-centre, RCT will be carried out to evaluate if direct hemoperfusion with polymyxin B immobilized fiber column (PMX) is superior to c...
Eligibility Criteria
Inclusion
- Patients with severe sepsis due to intra-abdominal cavity infection after emergency surgery with at least 2 SIRS criteria and 1 organ dysfunction (as defined by SCCM)
Exclusion
- Less than 18 years of age
- Females with a positive pregnancy test
- Treated with another investigational drug or device within the 30 days immediately preceding enrolment in this study
- Undergone organ transplantation during the past one year
- Documented history of sensitivity to Polymyxin-B, anticoagulant (heparin)
- Terminally ill, including metastases or hematological malignancy, with a life expectancy less than 30 days (as assessed by the attending physician) or have been classified as "Do Not Resuscitate"
- Diagnosed with HIV
- Previous history of end stage chronic organ failure(s)
- Uncontrolled hemorrhage within the last 24 h
- Diagnosed with granulocytopenia (leukocyte count of less than 500 cells/mm3) and/or thrombocytopenia (platelet count of less than 30,000 cells/mm3)
- More than 4 failed organs at entry
- An APACHE II score of more than 30 at entry to the study
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00629382
Start Date
December 1 2004
End Date
April 1 2008
Last Update
December 2 2008
Active Locations (1)
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1
St Bortolo Hospital
Vicenza, Italy, 36100