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Alterations of Immunologic Mediators During Severe Sepsis (LAVISS_01)

This study has been terminated.
(anticipated number of patients could not be reached)
Sponsor:
Collaborator:
University of Halle Medical Faculty
Information provided by (Responsible Party):
Armin Sablotzki, MD, Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier:
NCT00484146
First received: June 7, 2007
Last updated: October 26, 2012
Last verified: October 2012
History of Changes
  Purpose

Severe sepsis induces significant changes in expression of insulin- and toll-like receptors, cytokines, markers of apoptosis, and activation of t- and b-lymphocytes.


Condition
Severe Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alterations of Immunologic Mediators During Severe Sepsis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Klinikum St. Georg gGmbH:

Biospecimen Retention:   Samples Without DNA

Whole Blood Samples, Plasma Samples


Enrollment: 20
Study Start Date: June 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

In patients at early stage of severe sepsis, we investigate the expression of pro- and anti-inflammatory cytokines, chemokines, adhesion-molecules, toll-like receptors, insulin-receptors, markers of apoptosis und of t- and b-cell-activation on a mRNA level.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with early stage of severe sepsis and septic shock

Criteria

Inclusion Criteria:

  • age >= 18 y
  • agreement with study procedures
  • 3 of 4 SIRS-criteria
  • proven or highly suspected infection
  • 2 or more sepsis-induced organ failures
  • start of first sepsis-induced organ failure within the last 36 hours

Exclusion Criteria:

  • non-agreement with study procedures
  • signs of severe sepsis with organ failure > 36 hours
  • chronic immuno-compromising diseases
  • chronic therapy with anti-inflammatory drugs
  • non-curable cancer
  • chronic renal failure with hemodialysis
  • pregnancy or breast-feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484146

Locations
Germany
Klinikum St. Georg gGmbH, Interdisciplinary Intensive Care Unit
Leipzig, Sachsen, Germany, 04129
Sponsors and Collaborators
Klinikum St. Georg gGmbH
University of Halle Medical Faculty
Investigators
Principal Investigator: Armin R Sablotzki, MD Klinikum St. Georg gGmbH
  More Information

No publications provided

Responsible Party: Armin Sablotzki, MD, Prof. Dr. med., Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier: NCT00484146     History of Changes
Other Study ID Numbers: ISRCTN34508816, ISRCTN34508816
Study First Received: June 7, 2007
Last Updated: October 26, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Klinikum St. Georg gGmbH:
Sepsis
Early Stage
Immune System
Receptors
Cytokines

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

ClinicalTrials.gov processed this record on May 16, 2013