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

NCT01472952 | Withdrawn DMC

• 1 other identifier: 2011-211N-MA
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Trauma; Sepsis

Keywords

sepsis; immune cells; immune reaction; trauma; Immune activation

Outcome Measures

Primary Outcomes (1)

• Sepsis

  14 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critical care patients with multiple trauma

You may qualify if:

• multiple trauma,
• ISS \> 16

You may not qualify if:

• resuscitation
• pregnancy
• malignancy
• chronic renal insufficiency
• steroid intake

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Wounds and Injuries; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 17, 2011
• Study Start: February 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 21, 2014

Record last verified: 2014-10