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

This study has been completed.

Sponsors and Collaborators:	Charite University, Berlin, Germany German Research Foundation adexter GmbH
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00146432

Purpose

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

Condition	Intervention	Phase
Septicemia	Procedure: Immunoadsorption of LPS, IL-6 and C5a	Phase II Phase III

MedlinePlus related topics: Sepsis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment
Official Title:	Prospective, Controlled Pilot Trial: Treatment of Patients in Severe Sepsis and Septic Shock With Immunoadsorption of LPS, IL-6, C5a

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146432

Locations

Germany
Charite University Medicine Berlin
Berlin, Germany, 13353

Sponsors and Collaborators

Charite University, Berlin, Germany

German Research Foundation

adexter GmbH

Investigators

Principal Investigator:

Petra Reinke, MD, PhD

Charite, University Medicine Berlin, Germany

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Schefold JC, von Haehling S, Corsepius M, Pohle C, Kruschke P, Zuckermann H, Volk HD, Reinke P. A novel selective extracorporeal intervention in sepsis: immunoadsorption of endotoxin, interleukin 6, and complement-activating product 5a. Shock. 2007 Oct;28(4):418-25.

Study ID Numbers:	ISASS-1
Study First Received:	September 6, 2005
Last Updated:	September 6, 2005
ClinicalTrials.gov Identifier:	NCT00146432
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Sepsis
Shock
Shock, Septic
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009