TraumaNCT03319017
Apoptosis in Polymorphonuclear Cells and Inflammatory Cytokines of Trauma Patients
An observational study of Trauma, run by Korea University Guro Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- Multiple-trauma patients
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2017to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- The case where the check result of blood collection and oxygen saturation is able to influence treatment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Guro Hospital
Seoul, Guro-gu, 08308
Seung-hoe Song, MBE, 82-2-2626-1635, ssessong@korea.ac.kr
About this study
Official title: The Impact of Hypoxic Conditions on Apoptosis in Polymorphonuclear Cells and Inflammatory Cytokines of Trauma Patients at Emergency Department
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.
Read the 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.
- Conditions
- Trauma
- Being tested
- Multiple-trauma patients
- Keywords
- Hypoxia, Hyperinflammatory, Hyperoxia, Apoptosis, Oxygenation, Polymorphonuclear Cells, Tumor necrosis factor(TNF)-α, Cytokine
- Medical subject headings
- Wounds and Injuries, Hypoxia, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple-trauma patientsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Multiple-trauma patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure interleukin(IL)-6
- Measure in the separated plasma
- Analyze correlation with oxygen saturation
Measured: At the occurrence of the event during visiting an emergency room, up to 3 hours
Secondary outcomes (2)
Apoptosis of PMN check
A patient's whole blood is collected in the tube with ethylene
Measured: At the occurrence of the event during visiting an emergency room, up to 3 hours
tumor necrosis factor(TNF)-α
Measure in the separated plasma
Measured: At the occurrence of the event during visiting an emergency room, up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start1 Dec 2017
- Primary completion30 Nov 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University
- Responsible party
- Principal investigator, Jung-Youn Kim, Korea University Guro Hospital
- Investigators
- Jung-Youn Kim, MD, Ph.D., Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319017
- Sponsor's protocol ID
- KUGH17229 (trauma)
- Status last verified
- Dec 2017
- First submitted
- 17 Oct 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Moon S, Lee SH, Ryoo HW, Kim JK, Ahn JY, Kim SJ, Jeon JC, Lee KW, Sung AJ, Kim YJ, Lee DR, Do BS, Park SR, Lee JS. Preventable trauma death rate in Daegu, South Korea. Clin Exp Emerg Med. 2015 Dec 28;2(4):236-243. doi: 10.15441/ceem.15.085. eCollection 2015 Dec.
PubMed 27752603Deitch EA. Multiple organ failure. Pathophysiology and potential future therapy. Ann Surg. 1992 Aug;216(2):117-34. doi: 10.1097/00000658-199208000-00002.
PubMed 1503516Gillani S, Cao J, Suzuki T, Hak DJ. The effect of ischemia reperfusion injury on skeletal muscle. Injury. 2012 Jun;43(6):670-5. doi: 10.1016/j.injury.2011.03.008. Epub 2011 Apr 9.
PubMed 21481870Roumen RM, Redl H, Schlag G, Zilow G, Sandtner W, Koller W, Hendriks T, Goris RJ. Inflammatory mediators in relation to the development of multiple organ failure in patients after severe blunt trauma. Crit Care Med. 1995 Mar;23(3):474-80. doi: 10.1097/00003246-199503000-00010.
PubMed 7874897Giannoudis PV, Hildebrand F, Pape HC. Inflammatory serum markers in patients with multiple trauma. Can they predict outcome? J Bone Joint Surg Br. 2004 Apr;86(3):313-23. doi: 10.1302/0301-620x.86b3.15035. No abstract available.
PubMed 15125116Brach MA, deVos S, Gruss HJ, Herrmann F. Prolongation of survival of human polymorphonuclear neutrophils by granulocyte-macrophage colony-stimulating factor is caused by inhibition of programmed cell death. Blood. 1992 Dec 1;80(11):2920-4.
PubMed 1280481Ciesla DJ, Moore EE, Zallen G, Biffl WL, Silliman CC. Hypertonic saline attenuation of polymorphonuclear neutrophil cytotoxicity: timing is everything. J Trauma. 2000 Mar;48(3):388-95. doi: 10.1097/00005373-200003000-00004.
PubMed 10744274Elbim C, Estaquier J. Cytokines modulate neutrophil death. Eur Cytokine Netw. 2010 Mar;21(1):1-6. doi: 10.1684/ecn.2009.0183.
PubMed 20146984Greenberg S, Grinstein S. Phagocytosis and innate immunity. Curr Opin Immunol. 2002 Feb;14(1):136-45. doi: 10.1016/s0952-7915(01)00309-0.
PubMed 11790544Hsieh SC, Huang MH, Tsai CY, Tsai YY, Tsai ST, Sun KH, Yu HS, Han SH, Yu CL. The expression of genes modulating programmed cell death in normal human polymorphonuclear neutrophils. Biochem Biophys Res Commun. 1997 Apr 28;233(3):700-6. doi: 10.1006/bbrc.1997.6529.
PubMed 9168918Kim JY, Hong YS, Choi SH, Yoon YH, Moon SW, Lee SW. Effect of hypertonic saline on apoptosis of polymorphonuclear cells. J Surg Res. 2012 Nov;178(1):401-8. doi: 10.1016/j.jss.2012.01.055. Epub 2012 Mar 23.
PubMed 22475352Koller M, Clasbrummel B, Kollig E, Hahn MP, Muhr G. Major injury induces increased production of interleukin-10 in human granulocyte fractions. Langenbecks Arch Surg. 1998 Dec;383(6):460-5. doi: 10.1007/s004230050161.
PubMed 9921948Menger MD, Vollmar B. Surgical trauma: hyperinflammation versus immunosuppression? Langenbecks Arch Surg. 2004 Nov;389(6):475-84. doi: 10.1007/s00423-004-0472-0. Epub 2004 May 28.
PubMed 15173946Martin C, Boisson C, Haccoun M, Thomachot L, Mege JL. Patterns of cytokine evolution (tumor necrosis factor-alpha and interleukin-6) after septic shock, hemorrhagic shock, and severe trauma. Crit Care Med. 1997 Nov;25(11):1813-9. doi: 10.1097/00003246-199711000-00018.
PubMed 9366763
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Hypoxic Conditions on Apoptosis in Polymorphonuclear Cells and Inflammatory Cytokines of Trauma Patients at Emergency Department
- ClinicalTrials.gov ID
- NCT03319017
- Acronym / sponsor ID
- KUGH17229 (trauma)
- Conditions
- Trauma
- Keywords
- Hypoxia, Hyperinflammatory, Hyperoxia, Apoptosis, Oxygenation, Polymorphonuclear Cells, Tumor necrosis factor(TNF)-α, Cytokine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Korea University
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple-trauma patients | – | Procedure: Multiple-trauma patientsThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- The case where the check result of blood collection and oxygen saturation is able to influence treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple-trauma patientsThe 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. | Procedure or surgery | Multiple-trauma patients |
Primary outcome
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
2 secondary outcomes
Apoptosis of PMN check
Time frame: At the occurrence of the event during visiting an emergency room, up to 3 hours
tumor necrosis factor(TNF)-α
Time frame: At the occurrence of the event during visiting an emergency room, up to 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Background: PubMed 27752603Moon S, Lee SH, Ryoo HW, Kim JK, Ahn JY, Kim SJ, Jeon JC, Lee KW, Sung AJ, Kim YJ, Lee DR, Do BS, Park SR, Lee JS. Preventable trauma death rate in Daegu, South Korea. Clin Exp Emerg Med. 2015 Dec 28;2(4):236-243. doi: 10.15441/ceem.15.085. eCollection 2015 Dec.
- Background: PubMed 1503516Deitch EA. Multiple organ failure. Pathophysiology and potential future therapy. Ann Surg. 1992 Aug;216(2):117-34. doi: 10.1097/00000658-199208000-00002.
- Background: PubMed 21481870Gillani S, Cao J, Suzuki T, Hak DJ. The effect of ischemia reperfusion injury on skeletal muscle. Injury. 2012 Jun;43(6):670-5. doi: 10.1016/j.injury.2011.03.008. Epub 2011 Apr 9.
- Background: PubMed 7874897Roumen RM, Redl H, Schlag G, Zilow G, Sandtner W, Koller W, Hendriks T, Goris RJ. Inflammatory mediators in relation to the development of multiple organ failure in patients after severe blunt trauma. Crit Care Med. 1995 Mar;23(3):474-80. doi: 10.1097/00003246-199503000-00010.
- Background: PubMed 15125116Giannoudis PV, Hildebrand F, Pape HC. Inflammatory serum markers in patients with multiple trauma. Can they predict outcome? J Bone Joint Surg Br. 2004 Apr;86(3):313-23. doi: 10.1302/0301-620x.86b3.15035. No abstract available.
- Background: PubMed 1280481Brach MA, deVos S, Gruss HJ, Herrmann F. Prolongation of survival of human polymorphonuclear neutrophils by granulocyte-macrophage colony-stimulating factor is caused by inhibition of programmed cell death. Blood. 1992 Dec 1;80(11):2920-4.
- Background: PubMed 10744274Ciesla DJ, Moore EE, Zallen G, Biffl WL, Silliman CC. Hypertonic saline attenuation of polymorphonuclear neutrophil cytotoxicity: timing is everything. J Trauma. 2000 Mar;48(3):388-95. doi: 10.1097/00005373-200003000-00004.
- Background: PubMed 20146984Elbim C, Estaquier J. Cytokines modulate neutrophil death. Eur Cytokine Netw. 2010 Mar;21(1):1-6. doi: 10.1684/ecn.2009.0183.
- Background: PubMed 11790544Greenberg S, Grinstein S. Phagocytosis and innate immunity. Curr Opin Immunol. 2002 Feb;14(1):136-45. doi: 10.1016/s0952-7915(01)00309-0.
- Background: PubMed 9168918Hsieh SC, Huang MH, Tsai CY, Tsai YY, Tsai ST, Sun KH, Yu HS, Han SH, Yu CL. The expression of genes modulating programmed cell death in normal human polymorphonuclear neutrophils. Biochem Biophys Res Commun. 1997 Apr 28;233(3):700-6. doi: 10.1006/bbrc.1997.6529.
- Background: PubMed 22475352Kim JY, Hong YS, Choi SH, Yoon YH, Moon SW, Lee SW. Effect of hypertonic saline on apoptosis of polymorphonuclear cells. J Surg Res. 2012 Nov;178(1):401-8. doi: 10.1016/j.jss.2012.01.055. Epub 2012 Mar 23.
- Background: PubMed 9921948Koller M, Clasbrummel B, Kollig E, Hahn MP, Muhr G. Major injury induces increased production of interleukin-10 in human granulocyte fractions. Langenbecks Arch Surg. 1998 Dec;383(6):460-5. doi: 10.1007/s004230050161.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Youn Kim, MD, Ph.D. principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Youn Kim, MD, Ph.D. (82-2-2626-3285, yellowwizard@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure interleukin(IL)-6 (time frame: At the occurrence of the event during visiting an emergency room, up to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03319017, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2018.