Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis

PHASE4CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
Gram-Negative Bacterial InfectionsSepsisSeptic Shock
Interventions
DEVICE

Polymyxin B immobilized fiber column

Hemoperfusion with PMX will be performed in ICU. The 1st PMX treatment (day 0) will be carried out for 2 hours and ideally within 24 hours but not later than 48 hours after diagnosis of severe sepsis. The second PMX treatment has to be performed 24 to 48 hours after the end of the first PMX treatment, ideally after 24 hours. Hemoperfusion therapy will be performed in addition to conventional medical therapy in the ICU.

OTHER

Conventional medical therapy in the ICU

Including, but not limited to: antibiotic therapy, nutrition, administration of gamma-globulins, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, corrective measures for metabolic abnormalities, renal replacement therapy when appropriate.

Trial Locations (1)

36100

St Bortolo Hospital, Vicenza

All Listed Sponsors
lead

St. Bortolo Hospital

OTHER

NCT00629382 - Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis | Biotech Hunter | Biotech Hunter