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Alterations of Immunologic Mediators During Severe Sepsis (LAVISS_01)

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.
ClinicalTrials.gov Identifier: NCT00484146
Recruitment Status : Terminated (anticipated number of patients could not be reached)
First Posted : June 8, 2007
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Severe Sepsis

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.

Study Design

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alterations of Immunologic Mediators During Severe Sepsis
Study Start Date : June 2006
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. severity of sepsis [ Time Frame: 96 hours after diagnosis of sepsis ]
    SOFA-Score


Biospecimen Retention:   Samples Without DNA
Whole Blood Samples, Plasma Samples

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Armin Sablotzki, MD, Prof. Dr. med., Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier: NCT00484146     History of Changes
Other Study ID Numbers: ISRCTN34508816
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Keywords provided by Armin Sablotzki, MD, 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