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

Charité University Medicine Berlin

Status and phase: Completed; Phase 3; Phase 2

Conditions: Septicemia

Treatments: Procedure: Immunoadsorption of LPS, IL-6 and C5a

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00146432

ISASS-1

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)