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

NCT05441787 | Completed

• 2 other identifiers: PMT20222022R1I1A1A01068599
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

1\) Research Hypothesis

1. 1.Trauma -\> Inflammation -\> Severe inflammation -\> Poor prognosis
2. 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.
3. 3.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.
4. 4.Therefore, this study aimed to:

Conditions

Trauma Injury; Trauma, Multiple

Keywords

trauma; Blood collection; Serum mitochondria DNA; Delta neutrophil index; Cytokines

Outcome Measures

Primary Outcomes (2)

• Mortality (dichotomous)

  The number of deaths

  Within 30 days after trauma

• Multiorgan distress syndrome (dichotomous)

  The number of patients with SOFA ≥ 6

  Within 30 days after trauma

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• Injury severity score ≥ 16

You may not qualify if:

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

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Related Publications (10)

• 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.

  PMID: 32203541 BACKGROUND

• 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.

  PMID: 30504778 BACKGROUND

• 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.

  PMID: 19997055 BACKGROUND

• 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.

  PMID: 23787023 BACKGROUND

• 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.

  PMID: 31622590 BACKGROUND

• 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.

  PMID: 28414569 BACKGROUND

• 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.

  PMID: 24391478 BACKGROUND

• 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.

  PMID: 23979273 BACKGROUND

• 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.

  PMID: 26448617 BACKGROUND

• 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.

  PMID: 29633007 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. Circulating mitochondrial DNA (mtDNA) is released from injured tissue 2. Circulating mtDNA acts as a damage-associated molecule that activates neutrophils, which in turn release inflammatory cytokines, such as IL-1, IL-2, and IFN-γ, contributing to the development of a systemic inflammatory response syndrome (SIRS). 3. Some studies have reported that serum mtDNA levels may be associated with multi-organ dysfunction syndrome (MODS) and mortality in critically ill patients. 4. Clinical significance: Serum mtDNA, DNI, neutrophil counts, and inflammatory cytokines may change sequentially, and may be associated with SIRS and a poor prognosis, including higher risk for MODS and mortality, in critically ill patients.

MeSH Terms

Conditions

Accidental Injuries; Multiple Trauma; Wounds and Injuries

Study Officials

• Kwangmin Kim

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 1, 2022
• Study Start: July 25, 2022
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

KR (1)