Immunoadsorption of LPS, C5a and IL-6 in Severe Sepsis and Septic Shock (ISASS-1)

Phase 2

Completed

• Conditions: Septicemia

• Registration Number: NCT00146432
• Lead Sponsor: Charite University, Berlin, Germany

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 sepsis and septic shock

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-07
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-21
• Last Update Posted: 2009-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Trial Locations

Locations (1)

Charite University Medicine Berlin; 🇩🇪 Berlin, Germany