Status:
COMPLETED
Immunoadsorption of LPS, C5a and IL-6 in Severe Sepsis and Septic Shock (ISASS-1)
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
German Research Foundation
adexter GmbH
Conditions:
Septicemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether immunoadsorption of LPS, Il-6 and C5a reduces systemic hyperinflammation, improves immune function and improves organ function in patients with severe...
Eligibility Criteria
Inclusion
- Diagnosis of severe sepsis or septic shock (ACCP/SCCM)
- Presence of 4 SIRS criteria/indicators
- Suspected or proven infection (refer also to: 1.)
- Age 18-80
- APACHE II score \> 18
- At least one acute organ dysfunction (renal/pulmonary/hemodynamics/cerebral)
Exclusion
- Suspected or proven pregnancy
- Absolute contraindication for anticoagulation (active bleeding)
- Absolute IgA-deficiency
- History of anaphylactic reaction to egg-albumin
- Participants in other clinical trials (\<12 wks. prior to study inclusion)
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00146432
Last Update
August 25 2009
Active Locations (1)
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1
Charite University Medicine Berlin
Berlin, State of Berlin, Germany, 13353