Acute Respiratory Distress SyndromeNCT07774338
Serum sRAGE, CC16, and Syndecan-1 as Predictors of ARDS and Mortality After Severe Chest Trauma
An observational study of Acute Respiratory Distress Syndrome and Chest Trauma, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Chest Trauma
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 17Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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
- Being tested
- No intervention - observational study
- Keywords
- Severe chest trauma, Acute respiratory distress syndrome, sRANGE, CC16, Syndecan-1, Trauma biomarker
- Medical subject headings
- Respiratory Distress Syndrome, Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - observational studyOther
No intervention is assigned. Participants receive standard clinical care, and the study prospectively observes clinical outcomes and biomarkers following severe chest trauma.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention - observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From admission through 7 days
Secondary outcomes (5)
In-hospital mortality.
Measured: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 28 days after admission.
ICU length of stay.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From hospital admission until hospital discharge or death, with hospital length of stay assessed up to 28 days after admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WTMahran, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774338
- Sponsor's protocol ID
- Chest trauma Assiut2026
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Publications
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.
PubMed 29422518Bime 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.
PubMed 32599095Gao 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.
PubMed 41246543Xie 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.
PubMed 37878479Negrin 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.
PubMed 28380043Jabaudon 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.
PubMed 25932660Ahs 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.
PubMed 41864160Dixon 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.
PubMed 37678154Wei 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.
PubMed 38602081Lin 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.
PubMed 37047065Matthay 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.
PubMed 37487152Ma 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.
PubMed 40050633
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07774338
- Acronym / sponsor ID
- Chest trauma Assiut2026
- Conditions
- Acute Respiratory Distress Syndrome, Chest Trauma
- Keywords
- Severe chest trauma, Acute respiratory distress syndrome, sRANGE, CC16, Syndecan-1, Trauma biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Chest Trauma Cohort | – | Other: No intervention - observational studyAdults 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- Adult patients aged 18 - 60 years old.
Key exclusion criteria (17 listed)
- h. Age below 18 years or above 60 years old (to ensure a homogeneous adult study population and avoid age- related physiological differences).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - observational studyNo intervention is assigned. Participants receive standard clinical care, and the study prospectively observes clinical outcomes and biomarkers following severe chest trauma. | Other | Severe Chest Trauma Cohort |
Primary outcome
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
5 secondary outcomes
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 29422518Jabaudon 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.
- Background: PubMed 32599095Bime 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.
- Background: PubMed 41246543Gao 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.
- Background: PubMed 37878479Xie 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.
- Background: PubMed 28380043Negrin 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.
- Background: PubMed 25932660Jabaudon 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.
- Background: PubMed 41864160Ahs 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.
- Background: PubMed 37678154Dixon 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.
- Background: PubMed 38602081Wei 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.
- Background: PubMed 37047065Lin 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.
- Background: PubMed 37487152Matthay 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.
- Background: PubMed 40050633Ma 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome and Chest Trauma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wesam Mahran, Specialist of Emergency Medici (01028181966, Wesam.20134479@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of acute respiratory distress syndrome (ARDS), diagnosed according to the 2024 Global Definition of ARDS. (time frame: From admission through 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07774338, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.