Inflammation Severity and miRNA-126 in Trauma

NCT07291908 | Recruiting

• 1 other identifier: TBAEK-307
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Trauma triggers a complex immune response intended to eliminate danger signals and restore physiological balance. Early post-traumatic inflammation is primarily initiated by damage-associated molecular patterns (DAMPs) and pathogen-associated molecular patterns (PAMPs). In patients with severe trauma, dysregulated inflammation increases susceptibility to infection, systemic inflammatory response syndrome (SIRS), multiple organ dysfunction syndrome (MODS), and mortality. The lungs are particularly vulnerable, and excessive inflammatory activation may lead to acute lung injury (ALI) or acute respiratory distress syndrome (ARDS), conditions characterized by increased vascular permeability, alveolar epithelial injury, surfactant dysfunction, and impaired gas exchange. Pro-inflammatory cytokines, activated neutrophils, reactive oxygen species, and proteases contribute to endothelial and epithelial barrier disruption. Recent evidence also suggests that several microRNAs, including miR-126, may play a regulatory role in pulmonary barrier integrity through modulation of tight-junction proteins and PI3K/AKT-related pathways. Although many components of the trauma-related inflammatory response have been described, the relationship between systemic inflammatory severity and impairment of pulmonary gas exchange remains insufficiently defined in clinical settings. This study aims to investigate the correlation between inflammatory severity markers (C-reactive protein, procalcitonin, IL-6, reactive oxygen derivatives, neutrophil-to-lymphocyte ratio, lactate), imaging findings (flow-mediated dilation by ultrasound), clinical parameters (blood pressure, heart rate, urine output, vasoactive medication requirements), pulmonary gas-exchange measurements (arterial blood gases, PaO₂/FiO₂ ratio), and circulating miRNA-126 levels in trauma patients. The findings may help identify biomarkers that better reflect inflammatory burden and the risk of lung dysfunction following trauma.

Conditions

Trauma ICU Patients; Endothelial Injury

Keywords

ARDS; MULTITRAUMA; MICRORNAS; ENDOTHEL

Outcome Measures

Primary Outcomes (1)

• Correlation Between Serum miRNA-126 Levels and Severity of Lung Injury

  Measurement of circulating miRNA-126 levels and their correlation with pulmonary gas-exchange impairment (PaO₂/FiO₂ ratio, arterial blood gas parameters).

  First 3 days of ICU admission.

Secondary Outcomes (2)

• Serum IL-6 and Syndecan Levels

  First 3 days of ICU admission.

• Flow-Mediated Dilation (FMD) by Ultrasound

  Within first 3 days of ICU admission.

Study Arms (3)

Patients with ARDS and Were Followed in ICU After Trauma

Patients who developed ARDS and were followed in intensive care for at least 3 days after trauma

Patients without ARDS and Were Followed in ICU After Trauma

Patients who does not developed ARDS and were followed in intensive care for at least 3 days after trauma

Control Group

Control group of healthy volunteers of similar age and gender

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) admitted to the anesthesia intensive care units of Akdeniz University Faculty of Medicine with blunt or penetrating trauma. The population represents early post-traumatic ICU admissions without thoracic injury, pre-existing infection, immunodeficiency, or other conditions that may alter the inflammatory response.

You may qualify if:

• Adults aged 18 years or older.
• Patients monitored and treated for trauma in the anesthesia intensive care units of Akdeniz University Faculty of Medicine.

You may not qualify if:

• Patients younger than 18 years.
• Patients with concomitant thoracic trauma.
• Presence of active infection prior to trauma.
• Patients not admitted to the ICU within the first 24 hours after trauma.
• Patients who remain in the ICU for less than 72 hours following trauma.
• Current use of steroids, chemotherapy, or antibiotic therapy prior to ICU admission.
• Patients with immunodeficiency.
• Patients who are in shock prior to or during ICU admission.

Sponsors & Collaborators

• Melike Cengiz: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, Ağrı, 04200, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Johansson PI, Henriksen HH, Stensballe J, Gybel-Brask M, Cardenas JC, Baer LA, Cotton BA, Holcomb JB, Wade CE, Ostrowski SR. Traumatic Endotheliopathy: A Prospective Observational Study of 424 Severely Injured Patients. Ann Surg. 2017 Mar;265(3):597-603. doi: 10.1097/SLA.0000000000001751.

  PMID: 27144442 RESULT

• Lee LK, Medzikovic L, Eghbali M, Eltzschig HK, Yuan X. The Role of MicroRNAs in Acute Respiratory Distress Syndrome and Sepsis, From Targets to Therapies: A Narrative Review. Anesth Analg. 2020 Nov;131(5):1471-1484. doi: 10.1213/ANE.0000000000005146.

  PMID: 33079870 RESULT

Study Officials

• Melike Cengiz, Prof Dr

  Department of Anesthesiology and Reanimation, Akdeniz University Hospital

  STUDY DIRECTOR

• Canberk Kurban, Resident Physician

  Department of Anesthesiology and Reanimation, Akdeniz University Hospital

  PRINCIPAL INVESTIGATOR

• Şükran Burçak Yoldaş, Prof Dr

  Department of Medical Biology, Akdeniz University Hospital

  PRINCIPAL INVESTIGATOR

• Ülkü Arslan, Specialist Physician

  Department of Anesthesiology and Reanimation, Akdeniz University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melike Cengiz, Prof Dr

CONTACT

+905424317975; melikecengiz@yahoo.com

Canberk Kurban

CONTACT

+905393626841; canberkkrbn@gmail.comd

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): January 10, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Deidentified IPD and supporting documents will be available beginning 6 months after publication of the study results, and will remain accessible without a predefined end date.
• Access Criteria: Data will be shared with qualified researchers upon reasonable request. Investigators requesting access must submit: A short research proposal outlining study aims Institutional affiliation Ethics committee approval (if applicable) Access will be granted following the execution of a Data Use Agreement (DUA) to ensure protection of patient confidentiality.

Locations

TU (1)