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NCT07774338

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

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

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.

Official 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.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-10

Completion Date

2028-12

Last Updated

2026-08-19

Healthy Volunteers

Conditions

Acute Respiratory Distress Syndrome Chest Trauma

Interventions

OTHER

No intervention - observational study

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

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.