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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01472952
Enrollment
0
Registered
2011-11-17
Start date
2012-02-29
Completion date
2013-12-31
Last updated
2014-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Trauma

Keywords

sepsis, immune cells, immune reaction, trauma, Immune activation

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.

Interventions

None listed

Sponsors

Universitätsmedizin Mannheim
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* multiple trauma, * ISS \> 16

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Sepsis14 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026