Inflammation and the Host Response to Injury (Burns)
5. března 2019 aktualizováno: Ronald G. Tompkins, Massachusetts General Hospital
Inflammation and the Host Response to Injury
The purpose of this study is to help improve our understanding of the biology involved in the body's response to serious trauma or burn injury.
The host response to trauma and burns is a collection of physiological and pathophysiological processes that depend critically upon the regulation of the human innate immune system, with particular emphasis on the inflammatory component of that system.
No single research center or small group of centers has the capacity to delineate the integrated response of this complex biological system, which involves multiple molecular and genetic interactions that vary in time.
Our proposal promotes the identification of important dynamic relationships that regulate the integration of this complex biological system, with the expectation that this understanding will ultimately impact the diagnosis, prognosis, and treatment of the hospitalized, severely injured patient.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
This large-scale collaborative project provides the means to acquire the necessary new knowledge directly in humans.
Knowledge will be acquired using diverse state-of-the-art genomic and proteomic technologies, a highly complex clinical, proteomic, and genomic database, as well as newly-developed, novel analytical tools to probe this complex dataset.
Our analytical capabilities at the genomic and proteomic level are now rapidly evolving and our ability to link these genomic and proteomic data to pathways and functional modules will help us more closely link this cellular data to immunological processes and ultimately, to the phenotypic response (i.e., trajectory) in the injured host.
As a result, potential interventions, whether through our Program or other funding mechanisms, can be more effectively designed.
Typ studie
Pozorovací
Zápis (Očekávaný)
280
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Illinois
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Maywood, Illinois, Spojené státy, 60153
- Loyola University Medical Center at Loyola in Chicago
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Texas
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Dallas, Texas, Spojené státy, 75390
- Southwestern Medical Center at University of Texas Southwestern
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Galveston, Texas, Spojené státy, 77550
- University of Texas at Galveston-Shriners Burn Hospital- Galveston
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Washington
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Seattle, Washington, Spojené státy, 98104
- Harborview Medical Center at University of Washington
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Acute hospitalized burn patients
Popis
Inclusion Criteria:
- Burn patients of all ages with 20% or greater of total body surface area burns that require surgical treatment
- Burn patients admitted to the burn unit within 96 hours (4 days) of burn injury
All patients meeting these criteria are entered into the epidemiologic database and assessed for specific exclusion criteria to establish whether serial blood draws are warranted.
Exclusion Criteria:
- Injury caused by chemical agent
- Deep injury caused by conduction of electrical current or charge
- Decision not to treat due to severity of injury
- Anoxic brain injury that is not expected to result in complete recovery
- Associated multiple injuries exclusive of burns (ISS >=25)
- Pre-morbid condition: Severe congestive heart failure (measured ejection fraction <20%)
- Pre-morbid condition: Malignancy currently under treatment
- Pre-morbid condition: Medical condition requiring systemic glucocorticoid treatment
- Pre-morbid condition: current systemic immunosuppression for organ transplant or chronic inflammatory condition
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Time to death
Časové okno: Within two years of burn injury
|
Within two years of burn injury
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Change in gene expression after burn injury
Časové okno: Up to two years after burn injury
|
Up to two years after burn injury
|
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Number and type of complications
Časové okno: Up to two years after burn injury
|
Up to two years after burn injury
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Ronald G. Tompkins, MD, ScD, Massachusetts General Hospital
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Brownstein BH, Logvinenko T, Lederer JA, Cobb JP, Hubbard WJ, Chaudry IH, Remick DG, Baker HV, Xiao W, Mannick JA. Commonality and differences in leukocyte gene expression patterns among three models of inflammation and injury. Physiol Genomics. 2006 Feb 14;24(3):298-309. doi: 10.1152/physiolgenomics.00213.2005. Epub 2005 Dec 20.
- Lederer JA, Brownstein BH, Lopez MC, Macmillan S, Delisle AJ, Macconmara MP, Choudhry MA, Xiao W, Lekousi S, Cobb JP, Baker HV, Mannick JA, Chaudry IH; Inflammation and the Host Response to Injury Collaborative Research Program Participants. Comparison of longitudinal leukocyte gene expression after burn injury or trauma-hemorrhage in mice. Physiol Genomics. 2008 Feb 19;32(3):299-310. doi: 10.1152/physiolgenomics.00086.2007. Epub 2007 Nov 6.
- Russom A, Sethu P, Irimia D, Mindrinos MN, Calvano SE, Garcia I, Finnerty C, Tannahill C, Abouhamze A, Wilhelmy J, Lopez MC, Baker HV, Herndon DN, Lowry SF, Maier RV, Davis RW, Moldawer LL, Tompkins RG, Toner M; Inflammation and Host Response to Injury Large Scale Collaborative Research Program. Microfluidic leukocyte isolation for gene expression analysis in critically ill hospitalized patients. Clin Chem. 2008 May;54(5):891-900. doi: 10.1373/clinchem.2007.099150. Epub 2008 Mar 28.
- Kotz KT, Xiao W, Miller-Graziano C, Qian WJ, Russom A, Warner EA, Moldawer LL, De A, Bankey PE, Petritis BO, Camp DG 2nd, Rosenbach AE, Goverman J, Fagan SP, Brownstein BH, Irimia D, Xu W, Wilhelmy J, Mindrinos MN, Smith RD, Davis RW, Tompkins RG, Toner M; Inflammation and the Host Response to Injury Collaborative Research Program. Clinical microfluidics for neutrophil genomics and proteomics. Nat Med. 2010 Sep;16(9):1042-7. doi: 10.1038/nm.2205. Epub 2010 Aug 29.
- Xiao W, Mindrinos MN, Seok J, Cuschieri J, Cuenca AG, Gao H, Hayden DL, Hennessy L, Moore EE, Minei JP, Bankey PE, Johnson JL, Sperry J, Nathens AB, Billiar TR, West MA, Brownstein BH, Mason PH, Baker HV, Finnerty CC, Jeschke MG, Lopez MC, Klein MB, Gamelli RL, Gibran NS, Arnoldo B, Xu W, Zhang Y, Calvano SE, McDonald-Smith GP, Schoenfeld DA, Storey JD, Cobb JP, Warren HS, Moldawer LL, Herndon DN, Lowry SF, Maier RV, Davis RW, Tompkins RG; Inflammation and Host Response to Injury Large-Scale Collaborative Research Program. A genomic storm in critically injured humans. J Exp Med. 2011 Dec 19;208(13):2581-90. doi: 10.1084/jem.20111354. Epub 2011 Nov 21.
- Seok J, Warren HS, Cuenca AG, Mindrinos MN, Baker HV, Xu W, Richards DR, McDonald-Smith GP, Gao H, Hennessy L, Finnerty CC, Lopez CM, Honari S, Moore EE, Minei JP, Cuschieri J, Bankey PE, Johnson JL, Sperry J, Nathens AB, Billiar TR, West MA, Jeschke MG, Klein MB, Gamelli RL, Gibran NS, Brownstein BH, Miller-Graziano C, Calvano SE, Mason PH, Cobb JP, Rahme LG, Lowry SF, Maier RV, Moldawer LL, Herndon DN, Davis RW, Xiao W, Tompkins RG; Inflammation and Host Response to Injury, Large Scale Collaborative Research Program. Genomic responses in mouse models poorly mimic human inflammatory diseases. Proc Natl Acad Sci U S A. 2013 Feb 26;110(9):3507-12. doi: 10.1073/pnas.1222878110. Epub 2013 Feb 11.
- Warren HS, Tompkins RG, Mindrinos MN, Xiao W, Davis RW. Reply to Cauwels et al.: Of men, not mice, and inflammation. Proc Natl Acad Sci U S A. 2013 Aug 20;110(34):E3151. doi: 10.1073/pnas.1308943110. No abstract available.
- Silver GM, Klein MB, Herndon DN, Gamelli RL, Gibran NS, Altstein L, McDonald-Smith GP, Tompkins RG, Hunt JL; Inflammation and the Host Response to Trauma, Collaborative Research Program. Standard operating procedures for the clinical management of patients enrolled in a prospective study of Inflammation and the Host Response to Thermal Injury. J Burn Care Res. 2007 Mar-Apr;28(2):222-30. doi: 10.1097/BCR.0B013E318031AA44.
- Klein MB, Silver G, Gamelli RL, Gibran NS, Herndon DN, Hunt JL, Tompkins RG; Inflammation and the Host Response to Injury Investigators. Inflammation and the host response to injury: an overview of the multicenter study of the genomic and proteomic response to burn injury. J Burn Care Res. 2006 Jul-Aug;27(4):448-51. doi: 10.1097/01.BCR.0000227477.33877.E6.
- Klein MB, Hayden D, Elson C, Nathens AB, Gamelli RL, Gibran NS, Herndon DN, Arnoldo B, Silver G, Schoenfeld D, Tompkins RG. The association between fluid administration and outcome following major burn: a multicenter study. Ann Surg. 2007 Apr;245(4):622-8. doi: 10.1097/01.sla.0000252572.50684.49.
- Finnerty CC, Jeschke MG, Herndon DN, Gamelli R, Gibran N, Klein M, Silver G, Arnoldo B, Remick D, Tompkins RG; Investigators of the Inflammation and the Host Response Glue Grant. Temporal cytokine profiles in severely burned patients: a comparison of adults and children. Mol Med. 2008 Sep-Oct;14(9-10):553-60. doi: 10.2119/2007-00132.Finnerty.
- Qian WJ, Liu T, Petyuk VA, Gritsenko MA, Petritis BO, Polpitiya AD, Kaushal A, Xiao W, Finnerty CC, Jeschke MG, Jaitly N, Monroe ME, Moore RJ, Moldawer LL, Davis RW, Tompkins RG, Herndon DN, Camp DG, Smith RD; Inflammation and the Host Response to Injury Large Scale Collaborative Research Program. Large-scale multiplexed quantitative discovery proteomics enabled by the use of an (18)O-labeled "universal" reference sample. J Proteome Res. 2009 Jan;8(1):290-9. doi: 10.1021/pr800467r.
- Qian WJ, Petritis BO, Kaushal A, Finnerty CC, Jeschke MG, Monroe ME, Moore RJ, Schepmoes AA, Xiao W, Moldawer LL, Davis RW, Tompkins RG, Herndon DN, Camp DG 2nd, Smith RD; Inflammation and the Host Response to Injury Large Scale Collaborative Research Program. Plasma proteome response to severe burn injury revealed by 18O-labeled "universal" reference-based quantitative proteomics. J Proteome Res. 2010 Sep 3;9(9):4779-89. doi: 10.1021/pr1005026.
- Jeschke MG, Finnerty CC, Herndon DN, Song J, Boehning D, Tompkins RG, Baker HV, Gauglitz GG. Severe injury is associated with insulin resistance, endoplasmic reticulum stress response, and unfolded protein response. Ann Surg. 2012 Feb;255(2):370-8. doi: 10.1097/SLA.0b013e31823e76e7.
- Finnerty CC, Jeschke MG, Qian WJ, Kaushal A, Xiao W, Liu T, Gritsenko MA, Moore RJ, Camp DG 2nd, Moldawer LL, Elson C, Schoenfeld D, Gamelli R, Gibran N, Klein M, Arnoldo B, Remick D, Smith RD, Davis R, Tompkins RG, Herndon DN; Investigators of the Inflammation and the Host Response Glue Grant. Determination of burn patient outcome by large-scale quantitative discovery proteomics. Crit Care Med. 2013 Jun;41(6):1421-34. doi: 10.1097/CCM.0b013e31827c072e.
- Jeschke MG, Finnerty CC, Emdad F, Rivero HG, Kraft R, Williams FN, Gamelli RL, Gibran NS, Klein MB, Arnoldo BD, Tompkins RG, Herndon DN. Mild obesity is protective after severe burn injury. Ann Surg. 2013 Dec;258(6):1119-29. doi: 10.1097/SLA.0b013e3182984d19.
- Klein MB, Goverman J, Hayden DL, Fagan SP, McDonald-Smith GP, Alexander AK, Gamelli RL, Gibran NS, Finnerty CC, Jeschke MG, Arnoldo B, Wispelwey B, Mindrinos MN, Xiao W, Honari SE, Mason PH, Schoenfeld DA, Herndon DN, Tompkins RG; Inflammation and Host Response to Injury, and Large-Scale Collaborative Research Program. Benchmarking outcomes in the critically injured burn patient. Ann Surg. 2014 May;259(5):833-41. doi: 10.1097/SLA.0000000000000438.
- Tompkins RG. Survival from burns in the new millennium: 70 years' experience from a single institution. Ann Surg. 2015 Feb;261(2):263-8. doi: 10.1097/SLA.0000000000000623.
- Warren HS, Tompkins RG, Moldawer LL, Seok J, Xu W, Mindrinos MN, Maier RV, Xiao W, Davis RW. Mice are not men. Proc Natl Acad Sci U S A. 2015 Jan 27;112(4):E345. doi: 10.1073/pnas.1414857111. Epub 2014 Dec 24. No abstract available.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. dubna 2004
Primární dokončení (Aktuální)
1. září 2013
Dokončení studie (Aktuální)
1. září 2018
Termíny zápisu do studia
První předloženo
18. listopadu 2005
První předloženo, které splnilo kritéria kontroly kvality
18. listopadu 2005
První zveřejněno (Odhad)
22. listopadu 2005
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
7. března 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
5. března 2019
Naposledy ověřeno
1. března 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2 U54 GM062119_burn
- U54GM062119 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Curated and validated data are available to Consortium Members
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .