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

Sepsis Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01472952
• Other study ID #: 2011-211N-MA
• Status: Withdrawn
• Phase: N/A
• First received: November 9, 2011
• Last updated: October 20, 2014
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• multiple trauma,

• ISS > 16

Exclusion Criteria:

• resuscitation

• pregnancy

• malignancy

• chronic renal insufficiency

• steroid intake

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis
• Trauma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sepsis		14 days	No