- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06930222
The Investigation of Predicting Mortality and Morbidity in Patients Admitted to Intensive Care Unit With Thoracic Trauma Using Selected Biomarkers and Parameters
April 8, 2025 updated by: Suleyman Sencer CELİK, Suleyman Demirel University
This prospective study aimed to predict morbidity and mortality after thoracic trauma in intensive care unit evaluated clinical and biochemical data of 50 intensive care unit patients.
The research examined demographic factors such as gender, age, and smoking status, trauma scoring systems like ISS and RTS as well as biomarkers such as Surfactant-d and oxygenation parameters including the ROX index, PaO₂/FiO₂ ratio and FiO₂.
Study Overview
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Isparta, Turkey, 32260
- Suleyman Demirel University
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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
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with thoracic trauma admitted to icu
Description
Inclusion Criteria:
- Patients with thoracic trauma between the ages of 18-85
- Patients who have been monitored in intensive care for at least 1 week
Exclusion Criteria:
- Being outside the age range of 18-85
- Pregnant patients
- Patients whose intensive care follow-up lasted less than 1 week
- Patients who do not want to be included in the study
- Patients with a lung malignancy diagnosis before admission
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 |
|---|---|
|
thorax trauma patients
thorax trauma patients admitted to icu
|
blood samples obtained for 3 different days, limited to 5cc
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality Prediction Using ROX Index in Thoracic Trauma Patients
Time Frame: Measurements taken on day 1, day 3, and day 7 of hospitalization, following ICU admission.
|
To evaluate the predictive ability of the ROX index (unit: cmH₂O/L/s) for mortality in thoracic trauma patients.
ROX index values were recorded at 1st, 3rd, and 7th days of hospitalization using standard clinical monitoring and ventilatory support parameters.
Trends were analyzed in relation to survival outcomes.
|
Measurements taken on day 1, day 3, and day 7 of hospitalization, following ICU admission.
|
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Mortality Prediction Using SP-D Levels in Thoracic Trauma Patients
Time Frame: Measurements taken on day 1, day 3, and day 7 of hospitalization, following ICU admission.
|
To assess the prognostic value of Surfactant Protein D (SP-D) levels (unit: ng/mL) for mortality prediction in thoracic trauma patients.
SP-D levels were measured using an ELISA assay (Elabscience® Human Pulmonary Surfactant-associated Protein-D ELISA Kit) at 1st, 3rd, and 7th days to evaluate trends and correlations with survival outcomes.
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Measurements taken on day 1, day 3, and day 7 of hospitalization, following ICU admission.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Predictive Value of APACHE II Score in Mortality
Time Frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
|
To analyze the effectiveness of the APACHE II score (range: 0-71; higher scores indicate worse outcomes) in predicting mortality in thoracic trauma patients.
APACHE II scores were calculated based on clinical and laboratory parameters, including vital signs, blood gas values, and organ dysfunction markers at 1st, 3rd, and 7th days.
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Measurements taken on day 1, day 3, and day 7 of hospitalization.
|
|
Predictive Value of SOFA Score in Mortality
Time Frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
|
To evaluate the prognostic accuracy of the Sequential Organ Failure Assessment (SOFA) score (range: 0-24; higher scores indicate worse outcomes) in thoracic trauma patients.
SOFA scores were determined based on respiratory, cardiovascular, hepatic, coagulation, renal, and neurological functions at 1st, 3rd, and 7th days.
|
Measurements taken on day 1, day 3, and day 7 of hospitalization.
|
|
Predictive Value of TRISS Score in Mortality
Time Frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
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To examine the relationship between Trauma and Injury Severity Score (TRISS) (range: 0-100%; higher scores indicate better survival probability) and survival outcomes in thoracic trauma patients.
TRISS scores were calculated using physiological and anatomical injury severity data at 1st, 3rd, and 7th days.
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Measurements taken on day 1, day 3, and day 7 of hospitalization.
|
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Predictive Value of RTS Score in Mortality
Time Frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
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To assess the relationship between Revised Trauma Score (RTS) (range: 0-7.84; higher scores indicate better prognosis) and mortality risk in thoracic trauma patients.
RTS scores were calculated using Glasgow Coma Scale, systolic blood pressure, and respiratory rate values at 1st, 3rd, and 7th days.
|
Measurements taken on day 1, day 3, and day 7 of hospitalization.
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CRP Levels and Mortality Prediction
Time Frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
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To evaluate the association between C-reactive protein (CRP) levels (unit: mg/L) and mortality in thoracic trauma patients.
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Measurements taken on day 1, day 3, and day 7 of hospitalization.
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Procalcitonin Levels and Mortality Prediction
Time Frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
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To analyze the prognostic value of procalcitonin (unit: ng/mL) levels in mortality prediction among thoracic trauma patients.
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Measurements taken on day 1, day 3, and day 7 of hospitalization.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NEU/LYM Ratio and Mortality Correlation
Time Frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
|
To investigate the prognostic role of the Neutrophil-to-Lymphocyte Ratio (NEU/LYM) (unit: ratio value) in predicting mortality among thoracic trauma patients.
NEU/LYM values were obtained from complete blood count (CBC) results and recorded at 1st, 3rd, and 7th days
|
Measurements taken on day 1, day 3, and day 7 of hospitalization.
|
|
Glasgow Coma Scale (GCS) and Mortality Correlation
Time Frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
|
Description: To evaluate the predictive value of the Glasgow Coma Scale (GCS) score on mortality and other clinical outcomes in thoracic trauma patients. Score Range: 3-15 (lower scores indicate worse outcomes). |
Measurements taken on day 1, day 3, and day 7 of hospitalization.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: pınar karabacak, Suleyman Demirel 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
- Determann RM, Royakkers AA, Haitsma JJ, Zhang H, Slutsky AS, Ranieri VM, Schultz MJ. Plasma levels of surfactant protein D and KL-6 for evaluation of lung injury in critically ill mechanically ventilated patients. BMC Pulm Med. 2010 Feb 16;10:6. doi: 10.1186/1471-2466-10-6.
- Baker JE, Millar DA, Heh V, Goodman MD, Pritts TA, Janowak CF. Does chest wall Organ Injury Scale (OIS) or Abbreviated Injury Scale (AIS) predict outcomes? An analysis of 16,000 consecutive rib fractures. Surgery. 2020 Jul;168(1):198-204. doi: 10.1016/j.surg.2020.04.032. Epub 2020 May 13.
- Lundin A, Akram SK, Berg L, Goransson KE, Enocson A. Thoracic injuries in trauma patients: epidemiology and its influence on mortality. Scand J Trauma Resusc Emerg Med. 2022 Dec 12;30(1):69. doi: 10.1186/s13049-022-01058-6.
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 (Actual)
April 15, 2023
Primary Completion (Actual)
March 15, 2024
Study Completion (Actual)
April 15, 2024
Study Registration Dates
First Submitted
January 3, 2025
First Submitted That Met QC Criteria
April 8, 2025
First Posted (Actual)
April 16, 2025
Study Record Updates
Last Update Posted (Actual)
April 16, 2025
Last Update Submitted That Met QC Criteria
April 8, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SENCER-CELIK-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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