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临床试验/NCT05441787
NCT05441787已完成不适用

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 Hospital1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2022年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
试验地点
1
主要终点
Mortality (dichotomous)

研究概览

简要总结

  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.
  1. 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.

详细描述

  1. Research Objectives
  1. Quantitative measurement of serum mtDNA copy number (smtDNAcn), delta neutrophil index (DNI), and inflammatory cytokines [interleukin (IL) -1β/2/6/12, Interferon (IFN-ℽ), Tumor necrosis factor (TNF-α), IL-4/10)] over time
  2. Analysis of correlation between smtDNAcn, DNI, and inflammatory cytokines (IL-1β/2/6/12, IFN-ℽ, TNF-α, IL-4/10) at initial presentation, on trauma days #1 and #2, and poor outcomes [multiorgan distress syndrome (MODS), mortality]
  3. Construction and validation of a prognostic index using biological markers associated with inflammation (smtDNAcn, DNI, and inflammatory cytokines)
  1. Contents of the Research Project
  1. Measurement of biological indicators over time - Measurement of smtDNAcn, DNI, and inflammatory cytokines over time using polymerase chain reaction (PCR) and multiplex assay in patients classified as severely injured based on the injury severity score (ISS) (ISS ≥16).
  2. Analysis of correlation between biologic markers and poor outcomes (MODS, mortality) - Identification of independent risk factors to predict poor outcomes such as MODS and mortality among inflammatory markers (serum mtDNA copy number, DNI, neutrophil count, and inflammatory cytokines) in this study.
  3. Predictive Model Construction and Validation - Construction of a scoring system using inflammatory markers (smtDNAcn, DNI, neutrophils, and cytokines) and comparison with the SOFA score
  1. Strategies and methods for the research project

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Injury severity score ≥ 16

排除标准

  • Age ≤18 years
  • Pregnancy in women
  • Death at initial presentation of the case
  • Patients who refused to participate in the study

结局指标

主要结局

Mortality (dichotomous)

时间窗: Within 30 days after trauma

The number of deaths

Multiorgan distress syndrome (dichotomous)

时间窗: Within 30 days after trauma

The number of patients with SOFA ≥ 6

次要结局

  • Hospital length of stay (continuous)(From date of the admission until the date of first discharge from the hospital, assessed up to 60 days)
  • Intensive care unit (ICU) stay (continuous)(From date of ICU admission (in cases of ICU admission at the initial presentation) until the date of first discharge from ICU, assessed up to 60 days)

研究者

发起方
Wonju Severance Christian Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kwangmin Kim

Clinical assistant professor

Wonju Severance Christian Hospital

研究点 (1)

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