Skip to main content
Clinical Trials/NCT01472952
NCT01472952
Withdrawn
Not Applicable

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

Universitätsmedizin Mannheim0 sitesFebruary 2012
ConditionsTraumaSepsis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trauma
Sponsor
Universitätsmedizin Mannheim
Primary Endpoint
Sepsis
Status
Withdrawn
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
December 2013
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Timo Sturm

Principal Investigator

Universitätsmedizin Mannheim

Eligibility Criteria

Inclusion Criteria

  • multiple trauma,
  • ISS \> 16

Exclusion Criteria

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

Outcomes

Primary Outcomes

Sepsis

Time Frame: 14 days

Similar Trials