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
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, see Learn About Clinical Studies.

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:
Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on October 01, 2014