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

NCT07774338 | Not Yet Recruiting

• 1 other identifier: Chest trauma Assiut2026
• Study Type: observational
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Respiratory Distress Syndrome; Chest Trauma

Keywords

Severe chest trauma; Acute respiratory distress syndrome; sRANGE; CC16; Syndecan-1; Trauma biomarker

Outcome Measures

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

  From admission through 7 days

Secondary Outcomes (5)

• In-hospital mortality.

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

• ICU length of stay.

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

• Need for invasive mechanical ventilation

  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.

  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.

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

Study Arms (1)

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

Interventions

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.

Severe Chest Trauma Cohort

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (12)

• Jabaudon M, Berthelin P, Pranal T, Roszyk L, Godet T, Faure JS, Chabanne R, Eisenmann N, Lautrette A, Belville C, Blondonnet R, Cayot S, Gillart T, Pascal J, Skrzypczak Y, Souweine B, Blanchon L, Sapin V, Pereira B, Constantin JM. Receptor for advanced glycation end-products and ARDS prediction: a multicentre observational study. Sci Rep. 2018 Feb 8;8(1):2603. doi: 10.1038/s41598-018-20994-x.

  PMID: 29422518 BACKGROUND

• Bime C, Camp SM, Casanova N, Oita RC, Ndukum J, Lynn H, Garcia JGN. The acute respiratory distress syndrome biomarker pipeline: crippling gaps between discovery and clinical utility. Transl Res. 2020 Dec;226:105-115. doi: 10.1016/j.trsl.2020.06.010. Epub 2020 Jun 26.

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• Gao J, Rao T, Li Y, Gu W, Lu Q. Acute lung injury induced by traumatic hemorrhagic shock: pathogenesis, biomarkers and therapeutic perspectives. World J Emerg Med. 2025 Nov 1;16(6):532-542. doi: 10.5847/wjem.j.1920-8642.2025.119.

  PMID: 41246543 BACKGROUND

• Xie WW, Ding YJ, Bhandari S, Li H, Chen HS, Jin SW, Weng HX, Hao Y. CLINICAL VALUE OF SYNDECAN-1 LEVELS IN TRAUMA BRAIN INJURY: A META-ANALYSIS. Shock. 2024 Jan 1;61(1):49-54. doi: 10.1097/SHK.0000000000002255. Epub 2023 Oct 12.

  PMID: 37878479 BACKGROUND

• Negrin LL, Halat G, Kettner S, Gregori M, Ristl R, Hajdu S, Heinz T. Club cell protein 16 and cytokeratin fragment 21-1 as early predictors of pulmonary complications in polytraumatized patients with severe chest trauma. PLoS One. 2017 Apr 5;12(4):e0175303. doi: 10.1371/journal.pone.0175303. eCollection 2017.

  PMID: 28380043 BACKGROUND

• Jabaudon M, Blondonnet R, Roszyk L, Bouvier D, Audard J, Clairefond G, Fournier M, Marceau G, Dechelotte P, Pereira B, Sapin V, Constantin JM. Soluble Receptor for Advanced Glycation End-Products Predicts Impaired Alveolar Fluid Clearance in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2015 Jul 15;192(2):191-9. doi: 10.1164/rccm.201501-0020OC.

  PMID: 25932660 BACKGROUND

• Ahs EF, Gunther M. Biomarkers in Traumatic Lung Injury - A Systematic Review. J Surg Res. 2026 May;321:127-142. doi: 10.1016/j.jss.2026.02.018. Epub 2026 Mar 20.

  PMID: 41864160 BACKGROUND

• Dixon A, Kenny JE, Buzzard L, Holcomb J, Bulger E, Wade C, Fabian T, Schreiber M; PROPPR Study Group. Acute respiratory distress syndrome, acute kidney injury, and mortality after trauma are associated with increased circulation of syndecan-1, soluble thrombomodulin, and receptor for advanced glycation end products. J Trauma Acute Care Surg. 2024 Feb 1;96(2):319-325. doi: 10.1097/TA.0000000000004096. Epub 2023 Sep 6.

  PMID: 37678154 BACKGROUND

• Wei Y, Ren X, Yuan Z, Hong J, Wang T, Chen W, Xu Y, Ding J, Lin J, Jiang W, Zhang P, Wu Q. Trauma diagnostic-related target proteins and their detection techniques. Expert Rev Mol Med. 2024 Apr 11;26:e7. doi: 10.1017/erm.2024.3.

  PMID: 38602081 BACKGROUND

• Lin H, Liu Q, Zhao L, Liu Z, Cui H, Li P, Fan H, Guo L. Circulating Pulmonary-Originated Epithelial Biomarkers for Acute Respiratory Distress Syndrome: A Systematic Review and Meta-Analysis. Int J Mol Sci. 2023 Mar 23;24(7):6090. doi: 10.3390/ijms24076090.

  PMID: 37047065 BACKGROUND

• Matthay MA, Arabi Y, Arroliga AC, Bernard G, Bersten AD, Brochard LJ, Calfee CS, Combes A, Daniel BM, Ferguson ND, Gong MN, Gotts JE, Herridge MS, Laffey JG, Liu KD, Machado FR, Martin TR, McAuley DF, Mercat A, Moss M, Mularski RA, Pesenti A, Qiu H, Ramakrishnan N, Ranieri VM, Riviello ED, Rubin E, Slutsky AS, Thompson BT, Twagirumugabe T, Ware LB, Wick KD. A New Global Definition of Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2024 Jan 1;209(1):37-47. doi: 10.1164/rccm.202303-0558WS.

  PMID: 37487152 BACKGROUND

• Ma W, Tang S, Yao P, Zhou T, Niu Q, Liu P, Tang S, Chen Y, Gan L, Cao Y. Advances in acute respiratory distress syndrome: focusing on heterogeneity, pathophysiology, and therapeutic strategies. Signal Transduct Target Ther. 2025 Mar 7;10(1):75. doi: 10.1038/s41392-025-02127-9.

  PMID: 40050633 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Thoracic Injuries

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Wounds and Injuries

Central Study Contacts

Wesam Mahran, Specialist of Emergency Medici

CONTACT

01028181966; Wesam.20134479@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Emergency Medicine

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share