We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00146432
First Posted: September 7, 2005
Last Update Posted: August 25, 2009
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.
Collaborators:
German Research Foundation
adexter GmbH
Information provided by:
Charite University, Berlin, Germany
  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: 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 NLM:


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

  Eligibility

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: September 6, 2005
First Posted: September 7, 2005
Last Update Posted: August 25, 2009
Last Verified: August 2009

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