NCT05441787

The Usefulness of Inflammatory Markers to Predict Poor Outcomes for Trauma Patients

Completed Last updated 11 June 2024

What this trial tests

trial in Trauma Injury in 89 participants. Completed in 10 June 2024.

Timeline

25 July 2022

Primary endpoint
10 June 2024

10 June 2024

Quick facts

Lead sponsor	Wonju Severance Christian Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	89
Start date	25 July 2022
Primary completion	10 June 2024
Estimated completion	10 June 2024
Sites	1 location across South Korea

Conditions studied

• Trauma Injury — all drugs for Trauma Injury →
• Trauma, Multiple — all drugs for Trauma, Multiple →

Sponsor

Wonju Severance Christian Hospital

Who can join

19 and older, any sex, with Trauma Injury or Trauma, Multiple. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1\) Research Hypothesis

1. Trauma -\> Inflammation -\> Severe inflammation -\> Poor prognosis
2. If the degree of inflammation in the serum is precisely measurable, the prognosis of patients with trauma can be predicted. In addition, if inflammatory processes linked to serum mitochondrial DNA copy number (smtDNAcn) and delta neutrophil index (DNI) are demonstrated, early intervention to improve outcomes in patients with trauma and a poor prognosis may be possible.

2\) Basis of Research Hypothesis

1. 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.
2. 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mitochondrial VDAC1: A Potential Therapeutic Target of Inflammation-Related Diseases and Clinical Opportunities.
   Hu H, Guo L, Overholser J, Wang X. · · 2022 · cited 53× · PMID 36231136 · DOI 10.3390/cells11193174
2. Predictive value of elevated interleukin-33 levels for multi-organ dysfunction syndrome in trauma patients in South Korea: a prospective observational study.
   An S, Shin IS, Kim MJ, Kim DK, et al · · 2025 · PMID 41376400 · DOI 10.4266/acc.002500
3. Biomarkers to Predict Acute Kidney Injury in Patients with Trauma.
   Shin IS, Kim MJ, Kim DK, Sohn JH, et al · · 2025 · PMID 41155840 · DOI 10.3390/medicina61101853