An observational study in Acute Respiratory Distress Syndrome and Chest Trauma, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Assiut University · Observational
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.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 85 is below the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adult patients aged 18 - 60 years old.
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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 days
In-hospital mortality.
Time frame: 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.
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.
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.
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.
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared with other researchers.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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