- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05175872
Factors Affecting Mortality and Morbidity in Trauma Patients Followed in Intensive Care Unit (trauma)
Study Overview
Status
Conditions
Detailed Description
Trauma is an important health problem that causes increased morbidity and mortality. Most of the patients are taken into intensive care and followed up in intensive care with severe and multitrauma and constitute an important part of the critical diseases followed in the intensive care unit. At the same time, these fatal injuries cause a serious public health problem both economically and socially.
According to World Health Organization data, 5.8 million people die each year due to trauma. Trauma is seen more frequently at a young age and the most common cause is motor vehicle accidents and it is the first cause of death between 1-44 years. There is a strong relationship between deaths caused by trauma and factors such as age, gender, cause of trauma, and trauma area. In addition, the duration of ICU and mechanical ventilator stay, supportive treatments, trauma scores, and scores such as APACHE 2 and SOFA routinely used in intensive care have been shown to be strongly associated with mortality.
Therefore, the demographic data, trauma scores, mechanical ventilator requirement, renal failure, inotropic need, intensive care scores such as APACHE 2, SOFA, re-operation, re-operation, intensive care stay, blood replacement need, wound infection and morbidity and mortality in trauma patients will be effective.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Okmeydani Education and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Trauma Patients Followed up in the Intensive Care Unit between 14 October 2019 and 15 October 2021
- All trauma patients over the age of 18 who signed the informed consent form and agreed to participate in the trial
Exclusion Criteria:
- Patients under the age of 18
- Patients who refused to participate in the study
- Non-traumatic patients
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Injury Severity Score
Time Frame: during the procedure
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The Injury Severity Score (ISS) assesses the combined effects of the multiply-injured patients and is based on an anatomical injury severity classification. The ISS is calculated as the sum of the squares of the highest AIS code in each of the three most severely injured ISS body regions. These body regions are:
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during the procedure
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Clinical features
Time Frame: during the procedure
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Inotropic requirement, renal failure, mechanical ventilation requirement, re-operation, need for intensive care unit, blood replacement requirement, wound infection, discharge from intensive care unit, 28-day mortality, hospital mortality, mortality, number of stay days in intensive care unit during intensive care follow-up , 20/5000 history of drug use and hospital stay days will be recorded.
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during the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical Apgar Score
Time Frame: during the procedure
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Surgical Apgar Score (SAS) is used for predicting the occurrence of major postoperative morbidities and mortality after general and vascular surgery.
SAS is a 10-point score based on 3 easily obtained parameters: the estimated blood loss, lowest heart rate, and lowest mean arterial pressure during surgery
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during the procedure
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Collaborators and Investigators
Investigators
- Study Director: Namigar Turgut, Prof.Dr., Okmeydani Education and Research Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 928
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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