NCT03319017

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

January 4, 2018

Status Verified

December 1, 2017

Enrollment Period

12 months

First QC Date

October 17, 2017

Last Update Submit

January 3, 2018

Conditions

Keywords

HypoxiaHyperinflammatoryHyperoxiaApoptosisOxygenationPolymorphonuclear CellsTumor necrosis factor(TNF)-αCytokine

Outcome Measures

Primary Outcomes (1)

  • Measure interleukin(IL)-6

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

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

Secondary Outcomes (2)

  • Apoptosis of PMN check

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

  • tumor necrosis factor(TNF)-α

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

Study Arms (1)

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

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.

Multiple-trauma patients

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, Guro-gu, 08308, South Korea

RECRUITING

Related Publications (14)

  • 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.

    PMID: 27752603BACKGROUND
  • Deitch EA. Multiple organ failure. Pathophysiology and potential future therapy. Ann Surg. 1992 Aug;216(2):117-34. doi: 10.1097/00000658-199208000-00002.

    PMID: 1503516BACKGROUND
  • 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.

    PMID: 21481870BACKGROUND
  • 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.

    PMID: 7874897BACKGROUND
  • 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.

    PMID: 15125116BACKGROUND
  • 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.

    PMID: 1280481BACKGROUND
  • 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.

    PMID: 10744274BACKGROUND
  • Elbim C, Estaquier J. Cytokines modulate neutrophil death. Eur Cytokine Netw. 2010 Mar;21(1):1-6. doi: 10.1684/ecn.2009.0183.

    PMID: 20146984BACKGROUND
  • 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.

    PMID: 11790544BACKGROUND
  • 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.

    PMID: 9168918BACKGROUND
  • 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.

    PMID: 22475352BACKGROUND
  • 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.

    PMID: 9921948BACKGROUND
  • 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.

    PMID: 15173946BACKGROUND
  • 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.

    PMID: 9366763BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood collection

MeSH Terms

Conditions

Wounds and InjuriesHypoxiaHyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jung-Youn Kim, MD, Ph.D.

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Youn Kim, MD, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 24, 2017

Study Start

December 1, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

January 4, 2018

Record last verified: 2017-12

Locations