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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
  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:


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
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: 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
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 25, 2014