Clinical trial NCT03319017: Apoptosis in Polymorphonuclear Cells and Inflammatory Cytokines of Trauma Patients
Official title: The Impact of Hypoxic Conditions on Apoptosis in Polymorphonuclear Cells and Inflammatory Cytokines of Trauma Patients at Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma
Keywords: Hypoxia
Hyperinflammatory
Hyperoxia
Apoptosis
Oxygenation
Polymorphonuclear Cells
Tumor necrosis factor(TNF)-α
Cytokine
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
Collaborators: name: Korea University
First posted: 2017-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects of this study are patients with multiple severe trauma who have visited an emergency room in one year. this study is comparative observation research and have no intervention with treatment.

Brief summary: This study tries to find how hypoxia and hyperoxia, among types of the respiratory failure induced cell damage that can arise in the course of traumatic damage and treatment, influences apoptosis of PMN cells and IL-6 and tumor necrosis factor(TNF)-α as inflammatory cytokines.

Detailed description: Many patients visit an emergency room because of their trauma. Trauma patients account for around 25-35% in an emergency room. Trauma is the biggest cause of acquired disabilities, and is greatly related to death and disabilities of those aged less than 44. As such, since trauma leads to lowering personal life quality and greatly influences social and economic aspects, it is greatly dealt with in public medical service.

Primarily, patients with trauma experience a lot of bleeding and respiratory failure induced by multiple causes, and furthermore is likely to have hypovolaemic shock. Secondarily, the low blood flow induced by trauma and hypovolaemic shock triggers hypoxia and systemic inflammatory response syndrome(SIRS), and therefore lowering immunity leads to compensatory anti-inflammatory response syndrome(CARS). After that, failures to keep homeostasis, such as immune dysregulation induced acute respiratory distress syndrome (ARDS), multiple organ failure(MOF), immune function reduction, and inflammation overexpression, and other additional causes damage the patients who can end up being dead without recovery.

A trauma patient is able to be exposed to multiple complications of trauma and continue to have hypoxia and hyperoxia with multiple causes in the treatment step. Hypoxia triggers multiple organ failure by cell death and lack of oxygen, and especially is sensitive to nerve cells. Hyperoxia causes the problem of immunity system stimulation by oxygen radical and hydrogen peroxide(H2O2) secretion. As such, an oxygen condition can influence organ failure and inflammatory response in various ways. These hypoxia and hyperoxia are considered to be influential on post-trauma inflammation and on Polymorphonuclear Cells(PMN) and cytokine. A patient's oxygen condition control is the basic treatment of a trauma patient and is able to influence not only the maintenance of oxygen concentration in the body, but the immunity system for keeping body homeostasis to respond to trauma.

Therefore, it is important to know how a patient's oxygen condition influences cells in order to treat the patient. Nevertheless, there is no research on how hypoxia and hyperoxia influence PMN cell and inflammatory cytokine as inflammatory cells playing a critical role in post-trauma immunity function. Therefore, this study tries to find how hypoxia and hyperoxia, among types of the respiratory failure induced cell damage that can arise in the course of traumatic damage and treatment, influences apoptosis of PMN cells and IL-6 and tumor necrosis factor(TNF)-α as inflammatory cytokines. This study is expected to be used as a fundamental material for treating relevant patients.

Eligibility criteria: Inclusion Criteria:

* Adults aged more than 19
* The patients who are diagnosed with multiple-trauma and have blood test in an emergency room. The patients with multiple-trauma are defined as the patients who have trauma in more than two regions.

Exclusion Criteria:

* The case where the check result of blood collection and oxygen saturation is able to influence treatment

Primary outcomes:
measure: Measure interleukin(IL)-6
timeFrame: At the occurrence of the event during visiting an emergency room, up to 3 hours
Secondary outcomes:
measure: Apoptosis of PMN check
timeFrame: At the occurrence of the event during visiting an emergency room, up to 3 hours
measure: tumor necrosis factor(TNF)-α
timeFrame: At the occurrence of the event during visiting an emergency room, up to 3 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro-gu
Study officials:
affiliation: Assistant Professor
name: Jung-Youn Kim, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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