Septicemia Clinical Trial
Official title:
Prospective, Controlled Pilot Trial: Treatment of Patients in Severe Sepsis and Septic Shock With Immunoadsorption of LPS, IL-6, C5a
NCT number | NCT00146432 |
Other study ID # | ISASS-1 |
Secondary ID | |
Status | Completed |
Phase | Phase 2/Phase 3 |
First received | September 6, 2005 |
Last updated | August 21, 2009 |
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 sepsis and septic shock
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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) |
Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Charite University Medicine Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | adexter GmbH, German Research Foundation |
Germany,
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