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NCT00146432 Clinical Trial

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

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

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date August 2009
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
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)

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany Charite University Medicine Berlin Berlin

Sponsors (3)
Lead Sponsor Collaborator
Charite University, Berlin, Germany adexter GmbH, German Research Foundation

Country where clinical trial is conducted

Germany, 

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