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NCT00484146 Clinical Trial

Alterations of Immunologic Mediators During Severe Sepsis

Severe Sepsis Clinical Trial

— LAVISS_01  

Official title:
Alterations of Immunologic Mediators During Severe Sepsis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00484146
Other study ID # ISRCTN34508816
Secondary ID ISRCTN34508816
Status Terminated
Phase N/A
First received June 7, 2007
Last updated February 7, 2017
Start date June 2006
Est. completion date December 2012

Study information
Verified date February 2017
Source Klinikum St. Georg gGmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 20
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Klinikum St. Georg gGmbH, Interdisciplinary Intensive Care Unit Leipzig Sachsen

Sponsors (2)
Lead Sponsor Collaborator
Klinikum St. Georg gGmbH University of Halle Medical Faculty

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary severity of sepsis SOFA-Score 96 hours after diagnosis of sepsis
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