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The Sequential Organ Failure Assessment (SOFA) score is currently used as a measurement tool to evaluate the severity and prognosis of critically ill patients. Recently, some studies reported that the DNI, an inflammatory index, is useful as a prognostic index. Although DNI is a simple prognostic index, further studies are necessary to investigate its usefulness as a reliable prognostic index for severely injured patients.
Therefore, this study aimed to:
i. prospectively analyze the effectiveness of DNI by measuring the degree of inflammation in severely injured patients;
ii. Measure serum mitochondrial DNA, which is suggested as a mechanism preceding DNI elevation, and identify the sequence of inflammatory steps leading to circulating mitochondrial DNA as a damage-associated molecular pattern (DAMP), DNI, neutrophils, and inflammatory cytokines; and
iii. Establish the effectiveness of each indicator as a prognostic factor, construct a prediction model for poor prognosis, and prove the effectiveness of the final risk model.
Full description
A. Subjects: all trauma patients who visited Wonju Severance Christian hospital, regional trauma center.
Study period and patients recruitment
i. 1st and 2nd year (until construction of prognostic scoring system): 200 patients (MODS:50, mortality: 50)
ii. 3rd year (for validation): 100 patients (MODS: 30, mortality: 30)
Measurement of serum mtDNA copy number, DNI, and inflammatory cytokines
i. Blood sampling: At the initial presentation and again on trauma days #1 and #2.
ii. smtDNAcn, cytokines (IL-1β/2/6/12, IFN-ℽ, TNF-α, IL-4/10) by PCR, multiplex, and DNI using an automatic cell analyzer.
Analysis of correlation between biologic markers and poor outcomes (MODS, mortality)
i. Statistical analysis of inflammatory markers such as smtDNAcn, cytokines (IL-1β/2/6/12, IFN-ℽ, TNF-α, IL-4/10) measured at the initial presentation, on trauma day #1, and #2 between severely injured patients with no poor outcomes and those with poor outcomes such as MODS and mortality risk.
Risk model construction using inflammatory markers to predict MODS and mortality risk
i. Recruitment of 100 severely injured patients for validation on 3rd year during study period
ii. The recruited patients were divided into low-risk and high-risk groups according to the new risk model, cut-off value of each inflammatory marker, and SOFA score.
iii. Comparison of sensitivity and specificity of the new risk model, inflammatory markers, and SOFA score.
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Kwangmin Kim; In Sik Shin
Data sourced from clinicaltrials.gov
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