Serum sRAGE, CC16, and Syndecan-1 as Predictors of ARDS and Mortality After Severe Chest Trauma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
The study population will include adult patients aged 18 years or older admitted to the trauma unit with severe blunt or penetrating chest trauma. All eligible participants will undergo clinical assessment, routine laboratory and radiological evaluation, and single blood sampling for measurement of serum sRAGE, CC16, and Syndecan-1 levels. Participants will be followed prospectively for the development of ARDS during the first 7 days after admission, while in-hospital mortality will be recorded until hospital discharge or death.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention - observational study
Other interventionNo intervention is assigned. Participants receive standard clinical care, and the study prospectively observes clinical outcomes and biomarkers following severe chest trauma.
Treatment groups
85 Participants
are divided into 1 treatment groupGroup A: Severe Chest Trauma Cohort1 intervention
Trial outcomes
Primary outcomes
1
Development of acute respiratory distress syndrome (ARDS), diagnosed according to the 2024 Global Definition of ARDS.
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
Time frame
From admission through 7 daysSecondary 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
Requirement for invasive mechanical ventilation during hospitalization following severe chest trauma.
Time frame
Assessed daily from hospital admission through Day 7, or until initiation of invasive mechanical ventilation, hospital discharge, or death, whichever occurs first.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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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