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
Information provided by (Responsible Party):
Timo Sturm, University Hospital Mannheim Identifier:
First received: November 9, 2011
Last updated: November 16, 2011
Last verified: October 2011

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.


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

Resource links provided by NLM:

Further study details as provided by Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • Sepsis [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples

Estimated Enrollment: 30
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)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01472952

Contact: Timo Sturm, Dr. med. 0621 383 ext 3233

Sponsors and Collaborators
Universitätsmedizin Mannheim
  More Information

No publications provided

Responsible Party: Timo Sturm, Principal Investigator, University Hospital Mannheim Identifier: NCT01472952     History of Changes
Other Study ID Numbers: 2011-211N-MA
Study First Received: November 9, 2011
Last Updated: November 16, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsmedizin Mannheim:
immune cells
immune reaction
Immune activation

Additional relevant MeSH terms:
Wounds and Injuries
Systemic Inflammatory Response Syndrome
Pathologic Processes processed this record on October 16, 2014