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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00146432
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : August 25, 2009
German Research Foundation
adexter GmbH
Information provided by:
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

Condition or disease Intervention/treatment Phase
Septicemia Procedure: Immunoadsorption of LPS, IL-6 and C5a Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Controlled Pilot Trial: Treatment of Patients in Severe Sepsis and Septic Shock With Immunoadsorption of LPS, IL-6, C5a

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00146432

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Charite University Medicine Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation
adexter GmbH
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Principal Investigator: Petra Reinke, MD, PhD Charite, University Medicine Berlin, Germany
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00146432    
Other Study ID Numbers: ISASS-1
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes