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Alterations of Immunologic Mediators During Severe Sepsis

NCT ID: NCT00484146

Last Updated: 2017-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2012-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Severe Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Halle Medical Faculty

OTHER

Sponsor Role collaborator

Klinikum St. Georg gGmbH

OTHER

Sponsor Role lead

Responsible Party

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Armin Sablotzki, MD

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Armin R Sablotzki, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum St. Georg gGmbH

Locations

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Klinikum St. Georg gGmbH, Interdisciplinary Intensive Care Unit

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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ISRCTN34508816

Identifier Type: -

Identifier Source: secondary_id

ISRCTN34508816

Identifier Type: -

Identifier Source: org_study_id

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