ClinicalTrials.gg
Status unknownNCT03319017Updated Jan 4, 2018

Apoptosis in Polymorphonuclear Cells and Inflammatory Cytokines of Trauma Patients

An observational study in Trauma, sponsored by Korea University Guro Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-01-04.

Sponsored by Korea University Guro Hospital · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
19 Years and older
Sex
All
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Study 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 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.

02

Conditions studied

  • Trauma

Keywords

  • Hypoxia
  • Hyperinflammatory
  • Hyperoxia
  • Apoptosis
  • Oxygenation
  • Polymorphonuclear Cells
  • Tumor necrosis factor(TNF)-α
  • Cytokine
03

In context

Wounds and Injuries

2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.

This study's planned enrollment of 100 is below the median of 169 across 690 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Korea University Guro Hospital is the lead sponsor of 89 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • The case where the check result of blood collection and oxygen saturation is able to influence treatment
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • ProcedureMultiple-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.

06

What researchers measure

Primary outcomes

  1. Measure interleukin(IL)-6

    * Measure in the separated plasma * Analyze correlation with oxygen saturation

    Time frame: At the occurrence of the event during visiting an emergency room, up to 3 hours

Secondary outcomes

  1. Apoptosis of PMN check

    A patient's whole blood is collected in the tube with ethylene

    Time frame: At the occurrence of the event during visiting an emergency room, up to 3 hours

  2. tumor necrosis factor(TNF)-α

    Measure in the separated plasma

    Time frame: At the occurrence of the event during visiting an emergency room, up to 3 hours

07

Study locations

1 of 1 sites recruiting
  • Korea University Guro Hospital
    Seoul, Guro-gu 08308, Korea, Republic of
    Recruiting
08

References and documents

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 27752603 ↗
  • Deitch EA. Multiple organ failure. Pathophysiology and potential future therapy. Ann Surg. 1992 Aug;216(2):117-34. doi: 10.1097/00000658-199208000-00002. PubMed 1503516 ↗
  • Gillani 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 21481870 ↗
  • Roumen 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 7874897 ↗
  • Giannoudis 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 15125116 ↗
  • Brach 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 1280481 ↗
  • Ciesla 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 10744274 ↗
  • Elbim C, Estaquier J. Cytokines modulate neutrophil death. Eur Cytokine Netw. 2010 Mar;21(1):1-6. doi: 10.1684/ecn.2009.0183. PubMed 20146984 ↗
  • Greenberg 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 11790544 ↗
  • Hsieh 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 9168918 ↗
  • Kim 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 22475352 ↗
  • Koller 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 9921948 ↗
  • Menger 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 15173946 ↗
  • Martin 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2017 (actual). Primary completion is estimated for Nov 2018, 11 months after the start.

Of 265 non-industry observational studies under Wounds and Injuries, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's planned 11 months is below that.

Counting every sponsor, half of 312 studies reached it within 28 months; a quarter within 12 and three quarters within 60.

Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2017
First posted
Oct 24, 2017
StartActual
Dec 1, 2017
Primary completionEst.
Nov 30, 2018
CompletionEst.
Nov 30, 2018
Last update
Jan 4, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03319017
Lead sponsor
Korea University Guro Hospital
Collaborators
Korea University
Responsible party
Jung-Youn Kim (Assistant Professor, Korea University Guro Hospital) — Principal investigator
First posted
Oct 24, 2017
Start date
Dec 1, 2017
Primary completion
Nov 30, 2018 (estimated)
Completion
Nov 30, 2018 (estimated)
Last update
Jan 4, 2018

Study contacts

Jung-Youn Kim, MD, Ph.D.
Contact
yellowwizard@hanmail.net
82-2-2626-3285
Jung-Youn Kim, MD, Ph.D.
principal investigator · Assistant Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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