Status:
COMPLETED
Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock
Lead Sponsor:
Meditor SAS
Conditions:
Peritonitis
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this randomized, comparative, open and multi-centre study is to show that two sessions of hemoperfusion with Toraymyxin performed within maximum 36 hours after the surgery of a peritoni...
Detailed Description
The mortality rate due to peritonitis associated to a severe sepsis or a septic shock remains high (between 40 and 60% as per the studies). The recent complementary therapies for severe sepsis have be...
Eligibility Criteria
Inclusion
- Confirmed community or nosocomial acquired peritonitis due to organ perforation
- Septic shock requiring catecholamine infusion started or maintained 2 hours after surgery
Exclusion
- Pregnancy
- No severity criteria within the 8 hours following surgery
- Neutropenia due to chemotherapy or malignancy
- Abdominal sepsis without peritonitis
- Mesenteric ischemia without perforation
- Peritonitis due to appendicitis
- Perforation linked to trauma
- Cirrhosis child C
- Impossibility to use heparin
- Prolonged cardiac arrest within 72h before surgery
- Terminal disease diagnosed during surgery
- Moribund subjects
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT01222663
Start Date
October 1 2010
End Date
December 1 2013
Last Update
December 18 2013
Active Locations (18)
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1
Clermont-Ferrand University Hospital
Clermont-Ferrand, France, 63058
2
Dieppe Hospital
Dieppe, France, 76202
3
Vendée Hospital
La Roche-sur-Yon, France, 85925
4
Dr Schaffner Hospital
Lens, France, 62307