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

This study has been withdrawn prior to enrollment.
ClinicalTrials.gov Identifier:
First Posted: November 17, 2011
Last Update Posted: October 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Timo Sturm, Universitätsmedizin Mannheim

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.

Trauma Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Timo Sturm, Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • Sepsis [ Time Frame: 14 days ]

Biospecimen Retention:   Samples Without DNA
Blood samples

Enrollment: 0
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Critical care patients with multiple trauma

Inclusion Criteria:

  • multiple trauma,
  • ISS > 16

Exclusion Criteria:

  • resuscitation
  • pregnancy
  • malignancy
  • chronic renal insufficiency
  • steroid intake
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Timo Sturm, Principal Investigator, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT01472952     History of Changes
Other Study ID Numbers: 2011-211N-MA
First Submitted: November 9, 2011
First Posted: November 17, 2011
Last Update Posted: October 21, 2014
Last Verified: October 2014

Keywords provided by Timo Sturm, Universitätsmedizin Mannheim:
immune cells
immune reaction
Immune activation

Additional relevant MeSH terms:
Wounds and Injuries
Systemic Inflammatory Response Syndrome
Pathologic Processes