System-level Monitoring of Immune Activation Concerning Susceptibility to Sepsis in Trauma Patients

Withdrawn

• Conditions: Sepsis; Trauma

• Registration Number: NCT01472952
• Lead Sponsor: Universitätsmedizin Mannheim

Brief Summary

Sepsis remains a common entity in critical care patients with remarkable mortality. Despite extended research activities, no reliable bio-markers or scoring systems attributing the individual risk of developing sepsis have been found so far.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-17
• Study Start: 2012-02
• Primary Completion: 2013-07
• Study Completion: 2013-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-20
• Last Update Posted: 2014-10-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• multiple trauma,
• ISS > 16

Exclusion Criteria

• resuscitation
• pregnancy
• malignancy
• chronic renal insufficiency
• steroid intake

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sepsis	14 days