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

August 17, 2026 updated by: WTMahran, Assiut University

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Severe Chest Trauma Cohort
Adults aged 18 years or older with severe blunt or penetrating chest trauma admitted to the trauma unit and enrolled in the study. Participants will be followed prospectively for the development of acute respiratory distress syndrome and in-hospital mortality.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From admission through 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality.
Time Frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 28 days after admission.
From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 28 days after admission.
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.
From ICU admission until ICU discharge or death, with the outcome assessed up to 28 days after ICU admission.
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.
Assessed daily from hospital admission through Day 7, or until initiation of invasive mechanical ventilation, hospital discharge, or death, whichever occurs first.
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.
From initiation of invasive mechanical ventilation through Day 7, with assessment daily until successful extubation, death, hospital discharge, or Day 7, whichever occurs first.
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.
From hospital admission until hospital discharge or death, with hospital length of stay assessed up to 28 days after admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 12, 2026

First Submitted That Met QC Criteria

August 17, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chest trauma Assiut2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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