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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
      • Isparta, Turkey, 32260
        • Suleyman Demirel University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
thorax trauma patients
thorax trauma patients admitted to icu
Diagnostic test: blood sampling
blood samples obtained for 3 different days, limited to 5cc

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
Measurements taken on day 1, day 3, and day 7 of hospitalization, following ICU admission.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
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.
Measurements taken on day 1, day 3, and day 7 of hospitalization.
Predictive Value of RTS Score in Mortality
Time Frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
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.
CRP Levels and Mortality Prediction
Time Frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
To evaluate the association between C-reactive protein (CRP) levels (unit: mg/L) and mortality in thoracic trauma patients.
Measurements taken on day 1, day 3, and day 7 of hospitalization.
Procalcitonin Levels and Mortality Prediction
Time Frame: Measurements taken on day 1, day 3, and day 7 of hospitalization.
To analyze the prognostic value of procalcitonin (unit: ng/mL) levels in mortality prediction among thoracic trauma patients.
Measurements taken on day 1, day 3, and day 7 of hospitalization.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suleyman Demirel University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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