System-level Monitoring of Immune Activation Concerning Susceptibility to Sepsis in Trauma Patients
NCT ID: NCT01472952
Last Updated: 2014-10-21
Study Results
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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WITHDRAWN
OBSERVATIONAL
2012-02-29
2013-12-31
Brief Summary
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Patients with multiple trauma are at high risk of developing sepsis. Due to local and systemic immune reactions, high plasma levels of known pro-inflammatory cytokines can be found.
Simultaneously, certain anti-inflammatory reactions such as changes in immune cell activity and serum cytokine levels, known as "compensatory anti-inflammatory response syndrome" (CARS) take place.
In addition to changes of cytokine levels and immune cell activity, underlying genetic reactions are present. For instance, expression of miRNA (as an potential important step of immune cell activation) is likely changed during systemic and local immune reactions.
In the present study levels of pro- and antiinflammatory cytokines, a detailed assay of immune cell activation and the various expression of miRNA will be evaluated in patients of multiple trauma on day 1 and day 4.
Additionally, clinical parameters of organ function, current infection markers as CRP and Procalcitonin, cardiovascular function such as Indocyanin clearance and hemodynamic measures delivered with PiCCO-system and heart rate variability will be assessed. Parameters of local tissue perfusion will be measured with transcutaneous laser doppler.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* ISS \> 16
Exclusion Criteria
* pregnancy
* malignancy
* chronic renal insufficiency
* steroid intake
18 Years
ALL
Yes
Sponsors
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Universitätsmedizin Mannheim
OTHER
Responsible Party
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Timo Sturm
Principal Investigator
Other Identifiers
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2011-211N-MA
Identifier Type: -
Identifier Source: org_study_id
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