CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 89 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05441787
NCT05441787N/ACompleted

Comparison of Inflammatory Markers (Serum Mitochondrial DNA, Delta Neutrophil Index, Inflammatory Cytokines) According to the Injury Severity, and Development of Risk Prediction Model Using Inflammatory Markers for Trauma Patients

Wonju Severance Christian Hospital·observational·Posted Jul 1, 2022·Updated Jun 11, 2024

In Brief

An observational study for Trauma Injury and Trauma, Multiple. Completed, enrolled 89 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 1, 2022
Enrollment StartJul 25, 2022
Primary CompletionJun 10, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.0 years ago