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Trauma InjuryNCT05441787

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

An observational study of Trauma Injury and Trauma, Multiple, run by Wonju Severance Christian Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Trauma Injury, Trauma, Multiple
How many people
89 participants
Where
1 siteSouth Korea
Study dates
25 Jul 2022to 10 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All severely injured patients with injury severiry score ≥ 16 older than 19 years of age who visited Wonju Severance Christian Hospital, regional trauma center will be included in the study

Who may be able to join

  • Injury severity score ≥ 16

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

About this study

Official title: 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

  1. Research Hypothesis
  2. Trauma -> Inflammation -> Severe inflammation -> Poor prognosis
  3. 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.
  4. Basis of Research Hypothesis
  5. 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.
  6. Therefore, this study aimed to:
  7. 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.
Read the detailed description
  1. Research Objectives
  2. 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
  3. 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]
  4. Construction and validation of a prognostic index using biological markers associated with inflammation (smtDNAcn, DNI, and inflammatory cytokines)
  5. Contents of the Research Project
  6. 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).
  7. 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.
  8. Predictive Model Construction and Validation - Construction of a scoring system using inflammatory markers (smtDNAcn, DNI, neutrophils, and cytokines) and comparison with the SOFA score
  9. Strategies and methods for the research project
  10. A. Subjects: all trauma patients who visited Wonju Severance Christian hospital, regional trauma center.
  11. Study period and patients recruitment
  12. 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)
  13. Measurement of serum mtDNA copy number, DNI, and inflammatory cytokines
  14. 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.
  15. Analysis of correlation between biologic markers and poor outcomes (MODS, mortality)
  16. 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.
  17. Risk model construction using inflammatory markers to predict MODS and mortality risk
  18. 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.
Keywords
trauma, Blood collection, Serum mitochondria DNA, Delta neutrophil index, Cytokines
Medical subject headings
Accidental Injuries, Multiple Trauma, Wounds and Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality (dichotomous)

    The number of deaths

    Measured: Within 30 days after trauma

  2. Multiorgan distress syndrome (dichotomous)

    The number of patients with SOFA ≥ 6

    Measured: Within 30 days after trauma

Secondary outcomes (2)

  1. Hospital length of stay (continuous)

    Measured in days from admission to discharge

    Measured: From date of the admission until the date of first discharge from the hospital, assessed up to 60 days

  2. Intensive care unit (ICU) stay (continuous)

    Measured in days from ICU admission to ICU out

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2022
  2. Study start25 Jul 2022
  3. Primary completion10 Jun 2024
  4. Study completion10 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05441787
Sponsor's protocol ID
PMT2022
Other IDs
2022R1I1A1A01068599
Status last verified
Jun 2024
First submitted
23 Jun 2022
Last updated
11 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bang HJ, Kim K, Shim H, Kim S, Jung PY, Choi YU, Bae KS, Kim IY, Jang JY. Delta neutrophil index for predicting mortality in trauma patients who underwent emergent abdominal surgery: A case controlled study. PLoS One. 2020 Mar 23;15(3):e0230149. doi: 10.1371/journal.pone.0230149. eCollection 2020.

    PubMed 32203541

  • Kong T, Park YS, Lee HS, Kim S, Lee JW, You JS, Chung HS, Park I, Chung SP. The delta neutrophil index predicts development of multiple organ dysfunction syndrome and 30-day mortality in trauma patients admitted to an intensive care unit: a retrospective analysis. Sci Rep. 2018 Nov 30;8(1):17515. doi: 10.1038/s41598-018-35796-4.

    PubMed 30504778

  • Zhang Q, Itagaki K, Hauser CJ. Mitochondrial DNA is released by shock and activates neutrophils via p38 map kinase. Shock. 2010 Jul;34(1):55-9. doi: 10.1097/SHK.0b013e3181cd8c08.

    PubMed 19997055

  • Yamanouchi S, Kudo D, Yamada M, Miyagawa N, Furukawa H, Kushimoto S. Plasma mitochondrial DNA levels in patients with trauma and severe sepsis: time course and the association with clinical status. J Crit Care. 2013 Dec;28(6):1027-31. doi: 10.1016/j.jcrc.2013.05.006. Epub 2013 Jun 18.

    PubMed 23787023

  • Faust HE, Reilly JP, Anderson BJ, Ittner CAG, Forker CM, Zhang P, Weaver BA, Holena DN, Lanken PN, Christie JD, Meyer NJ, Mangalmurti NS, Shashaty MGS. Plasma Mitochondrial DNA Levels Are Associated With ARDS in Trauma and Sepsis Patients. Chest. 2020 Jan;157(1):67-76. doi: 10.1016/j.chest.2019.09.028. Epub 2019 Oct 14.

    PubMed 31622590

  • Hu Q, Ren J, Wu J, Li G, Wu X, Liu S, Wang G, Gu G, Li J. Elevated Levels of Plasma Mitochondrial DNA Are Associated with Clinical Outcome in Intra-Abdominal Infections Caused by Severe Trauma. Surg Infect (Larchmt). 2017 Jul;18(5):610-618. doi: 10.1089/sur.2016.276. Epub 2017 Apr 17.

    PubMed 28414569

  • Nakahira K, Kyung SY, Rogers AJ, Gazourian L, Youn S, Massaro AF, Quintana C, Osorio JC, Wang Z, Zhao Y, Lawler LA, Christie JD, Meyer NJ, Mc Causland FR, Waikar SS, Waxman AB, Chung RT, Bueno R, Rosas IO, Fredenburgh LE, Baron RM, Christiani DC, Hunninghake GM, Choi AM. Circulating mitochondrial DNA in patients in the ICU as a marker of mortality: derivation and validation. PLoS Med. 2013 Dec;10(12):e1001577; discussion e1001577. doi: 10.1371/journal.pmed.1001577. Epub 2013 Dec 31.

    PubMed 24391478

  • Simmons JD, Lee YL, Mulekar S, Kuck JL, Brevard SB, Gonzalez RP, Gillespie MN, Richards WO. Elevated levels of plasma mitochondrial DNA DAMPs are linked to clinical outcome in severely injured human subjects. Ann Surg. 2013 Oct;258(4):591-6; discussion 596-8. doi: 10.1097/SLA.0b013e3182a4ea46.

    PubMed 23979273

  • Krychtiuk KA, Ruhittel S, Hohensinner PJ, Koller L, Kaun C, Lenz M, Bauer B, Wutzlhofer L, Draxler DF, Maurer G, Huber K, Wojta J, Heinz G, Niessner A, Speidl WS. Mitochondrial DNA and Toll-Like Receptor-9 Are Associated With Mortality in Critically Ill Patients. Crit Care Med. 2015 Dec;43(12):2633-41. doi: 10.1097/CCM.0000000000001311.

    PubMed 26448617

  • Thurairajah K, Briggs GD, Balogh ZJ. The source of cell-free mitochondrial DNA in trauma and potential therapeutic strategies. Eur J Trauma Emerg Surg. 2018 Jun;44(3):325-334. doi: 10.1007/s00068-018-0954-3. Epub 2018 Apr 9.

    PubMed 29633007

Questions about this trial

What is this clinical trial studying?

An observational study of Trauma Injury and Trauma, Multiple, run by Wonju Severance Christian Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (dichotomous) (time frame: Within 30 days after trauma). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05441787, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.

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