Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07774338

Serum sRAGE, CC16, and Syndecan-1 as Predictors of ARDS and Mortality After Severe Chest Trauma

This prospective cohort study aims to evaluate whether blood levels of soluble receptor for advanced glycation end products (sRAGE), Club Cell Protein-16 (CC16), and Syndecan-1 measured early after severe chest trauma can predict the development of acute respiratory distress syndrome (ARDS) and in-hospital mortality. Adult patients aged 18 years or older admitted with severe blunt or penetrating chest trauma will be enrolled. Clinical data, injury severity, laboratory findings, imaging results, and clinical outcomes will be recorded. Patients will be followed daily during the first 7 days after admission for the development of ARDS, and in-hospital mortality will be recorded until discharge or death. The findings may help identify patients at high risk of respiratory complications and poor outcomes after severe chest trauma.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged 18 - 60 years old.
  • Patients with blunt or penetrating severe chest trauma.
  • Chest Abbreviated Injury Scale (Chest AIS ≥3).
  • Admission within 24 hours of injury.
  • Patients admitted to the Trauma Unit or Trauma ICU.
  • Written informed consent obtained from the patient or legally authorized representative.

Exclusion criteria

  • h. Age below 18 years or above 60 years old (to ensure a homogeneous adult study population and avoid age- related physiological differences).
  • i. Hospital admission more than 24 hours after injury (to ensure early biomarker measurement before secondary inflammatory changes occur).
  • j. Previous diagnosis of acute respiratory distress syndrome before admission (to ensure that ARDS outcomes are attributable to the index chest trauma).
  • k. Pre-existing chronic interstitial lung disease (to avoid baseline pulmonary abnormalities that may influence biomarker levels and respiratory outcomes).
  • l. Acute exacerbation of chronic obstructive pulmonary disease requiring hospitalization (to minimize confounding from pre-existing acute pulmonary inflammation).
  • m. Active pulmonary infection before trauma (to exclude pre-existing pulmonary inflammation that may alter biomarker levels and increase the risk of ARDS independently of trauma).
  • n. End-stage chronic liver disease (to avoid altered inflammatory responses and poor clinical outcomes unrelated to chest trauma).
  • o. End-stage renal disease requiring dialysis (to avoid altered clearance of circulating biomarkers and independently increased mortality risk).
  • p. Active malignancy receiving chemotherapy or radiotherapy (to exclude patients with cancer-related systemic inflammation and immunosuppression that may affect biomarker levels and outcomes).
  • q. Pregnancy (because physiological changes during pregnancy may influence biomarker levels and respiratory function).
  • r. Patients transferred from another hospital more than 24 hours after injury (to ensure standardized early clinical assessment and biomarker sampling within the predefined study period).
  • s. Refusal to participate in the study (because informed consent is required for study enrollment).
  • t. Connective tissue diseases
  • u. Severe burns and major inhalational injury v. Immunosuppressive therapy
  • w. Chronic systemic inflammatory diseases
  • x. Severe obesity ( BMI>40), if relevant.
  • y. Poly trauma with AIS> or = 3 outside the chest.

Treatment and study plan

NO intervention - observational study

Other

No intervention is assigned. Participants receive standard clinical care, and the study prospectively observes clinical outcomes and biomarkers following severe chest trauma.

Primary outcomes

  1. Development of acute respiratory distress syndrome (ARDS), diagnosed according to the 2024 Global Definition of ARDS.

    Time frame: From admission through 7 days

    Acute respiratory distress syndrome (ARDS) will be diagnosed according to the 2024 Global Definition of ARDS, which updates and expands the Berlin Definition. ARDS is defined by acute hypoxemic respiratory failure occurring within one week of a known clinical insult, with bilateral pulmonary opacities on chest imaging (chest radiography, computed tomography, or lung ultrasound) not fully explained by cardiac failure or fluid overload, and impaired oxygenation (PaO₂/FiO₂ ≤300 mmHg or SpO₂/FiO₂ ≤315 under specified respiratory support). Severity is classified as mild, moderate, or severe according to the degree of hypoxemia). Two independent intensivists blinded to biomarker results will independently adjudicate ARDS diagnosis according to the 2024 Global Definition Two independent intensivists blinded to biomarker results will independently adjudicate ARDS diagnosis according to the 2024 Global Definition

Secondary outcomes

  1. In-hospital mortality.

    Time frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 28 days after admission.

  2. ICU length of stay.

    Time frame: From ICU admission until ICU discharge or death, with the outcome assessed up to 28 days after ICU admission.

  3. Need for invasive mechanical ventilation

    Time frame: Assessed daily from hospital admission through Day 7, or until initiation of invasive mechanical ventilation, hospital discharge, or death, whichever occurs first.

    Requirement for invasive mechanical ventilation during hospitalization following severe chest trauma.

  4. Duration of mechanical ventilation.

    Time frame: From initiation of invasive mechanical ventilation through Day 7, with assessment daily until successful extubation, death, hospital discharge, or Day 7, whichever occurs first.

  5. Hospital length of stay.

    Time frame: From hospital admission until hospital discharge or death, with hospital length of stay assessed up to 28 days after admission.

Study contacts

Contact information is provided by the study sponsor or research team.

Wesam Mahran, Specialist of Emergency Medici

CONTACT

[email protected]

01028181966

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Early Admission Serum Soluble Receptor for Advanced Glycation End Products (sRAGE), Club Cell Protein-16 (CC16), and Syndecan-1 as Independent Predictors of Acute Respiratory Distress Syndrome and In-Hospital Mortality Following Severe Isolated Chest Trauma: A Prospective Cohort Study.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.