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

This study has been completed.
Sponsor:
Collaborators:
German Research Foundation
adexter GmbH
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00146432
First received: September 6, 2005
Last updated: August 21, 2009
Last verified: August 2009
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: 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 NLM:


Further study details as provided by Charite University, Berlin, Germany:

  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

Additional Information:
No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00146432     History of Changes
Other Study ID Numbers: ISASS-1
Study First Received: September 6, 2005
Last Updated: August 21, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Toxemia
Sepsis
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on April 17, 2014