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Apoptosis in Polymorphonuclear Cells and Inflammatory Cytokines of Trauma Patients

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ClinicalTrials.gov Identifier: NCT03319017
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : January 4, 2018
Sponsor:
Collaborator:
Korea University
Information provided by (Responsible Party):
Jung-Youn Kim, Korea University Guro Hospital

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.

Condition or disease Intervention/treatment
Trauma Procedure: Multiple-trauma patients

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Impact of Hypoxic Conditions on Apoptosis in Polymorphonuclear Cells and Inflammatory Cytokines of Trauma Patients at Emergency Department
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Multiple-trauma patients
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.
Procedure: Multiple-trauma patients

The blood samples of the patients who agreed on this research are obtained in order to check their inflammatory response factor, and then their medical records are checked to find their initial ABGA result, lactate, C-reactive protein(CRP) known as initial inflammatory response, and procalcitonin.

A patient's whole blood is collected in the tube with ethylene diaminetetracetic acid (EDTA) treatment. A modified method of Boyum's technique is applied so as to separate polymorphonuclear neutrophils. The separated polymorphonuclear neutrophils is collected so as to check apoptosis. And then, in the separated plasma, interleukin(IL)-6 and tumor necrosis factor(TNF)-α are measured, and its correlation with oxygen saturation will be analyzed.





Primary Outcome Measures :
  1. Measure interleukin(IL)-6 [ Time Frame: At the occurrence of the event during visiting an emergency room, up to 3 hours ]
    • Measure in the separated plasma
    • Analyze correlation with oxygen saturation


Secondary Outcome Measures :
  1. Apoptosis of PMN check [ Time Frame: At the occurrence of the event during visiting an emergency room, up to 3 hours ]
    A patient's whole blood is collected in the tube with ethylene

  2. tumor necrosis factor(TNF)-α [ Time Frame: At the occurrence of the event during visiting an emergency room, up to 3 hours ]
    Measure in the separated plasma


Biospecimen Retention:   Samples With DNA
Whole blood collection


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319017


Contacts
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Contact: Jung-Youn Kim, MD, Ph.D. 82-2-2626-3285 yellowwizard@hanmail.net

Locations
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Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Guro-gu, Korea, Republic of, 08308
Contact: Seung-hoe Song, MBE    82-2-2626-1635    ssessong@korea.ac.kr   
Sponsors and Collaborators
Korea University Guro Hospital
Korea University
Investigators
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Principal Investigator: Jung-Youn Kim, MD, Ph.D. Assistant Professor

Publications:

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Responsible Party: Jung-Youn Kim, Assistant Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT03319017     History of Changes
Other Study ID Numbers: KUGH17229 (trauma)
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jung-Youn Kim, Korea University Guro Hospital:
Hypoxia
Hyperinflammatory
Hyperoxia
Apoptosis
Oxygenation
Polymorphonuclear Cells
Tumor necrosis factor(TNF)-α
Cytokine
Additional relevant MeSH terms:
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Wounds and Injuries