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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Timo Sturm, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier:
NCT01472952
First received: November 9, 2011
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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.


Condition
Trauma
Sepsis

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


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)
  Eligibility

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

Criteria

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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Timo Sturm, Principal Investigator, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT01472952     History of Changes
Other Study ID Numbers: 2011-211N-MA
Study First Received: November 9, 2011
Last Updated: October 20, 2014
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Sepsis
Toxemia
Wounds and Injuries
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 22, 2014