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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Universitätsmedizin Mannheim.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Timo Sturm, University Hospital Mannheim
ClinicalTrials.gov Identifier:
NCT01472952
First received: November 9, 2011
Last updated: November 16, 2011
Last verified: October 2011

November 9, 2011
November 16, 2011
February 2012
July 2013   (final data collection date for primary outcome measure)
Sepsis [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01472952 on ClinicalTrials.gov Archive Site
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System-level Monitoring of Immune Activation Concerning Susceptibility to Sepsis in Trauma Patients
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Blood samples

Non-Probability Sample

Critical care patients with multiple trauma

  • Trauma
  • Sepsis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
December 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • multiple trauma,
  • ISS > 16

Exclusion Criteria:

  • resuscitation
  • pregnancy
  • malignancy
  • chronic renal insufficiency
  • steroid intake
Both
18 Years and older
Yes
Contact: Timo Sturm, Dr. med. 0621 383 ext 3233 timo.sturm@umm.de
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NCT01472952
2011-211N-MA
Yes
Timo Sturm, University Hospital Mannheim
Universitätsmedizin Mannheim
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Universitätsmedizin Mannheim
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP