Neutrophil Extracellular Traps and Neonatal (PV4991) & Pediatric Sepsis (PV5063)
Studieoversigt
Detaljeret beskrivelse
Severe infection resulting in sepsis is recognized as a leading cause of morbidity and mortality worldwide (Stehr and Reinhart, 2013). The incidence of sepsis in developed nations has been increasing while overall mortality is decreasing, but still remains around 30% (Mayr et al., 2014). Moreover, morbidity in survivors is often functionally devastating, and may include neurological impairment, chronic organ dysfunction, increased days admitted to hospital, and high rates of mortality postdischarge (Prescott et al., 2014). Emotional, social, and financial costs to individuals and health care systems are immense (Brun-Buisson et al., 2003).
Neutrophils are the first line of innate immune defense against infectious agents. In addition, neutrophils' ability to eliminate pathogens by phagocytosis and/or degranulation, it has recently been demonstrated that neutrophils can bind to and kill a wide range of microorganisms by forming neutrophil extracellular traps (NETs) (Brinkmann et al., 2004). This novel mechanism consists of the release of web-like structures of DNA decorated with histones and antimicrobial proteins, known as NETs. Microbes are immobilized in these traps, which contain a lethal concentration of antimicrobial agents killing a broad range of microorganisms, including gram-negative and gram-positive bacteria, fungi, viruses, and protozoa (Brinkmann et al., 2004, Fuchs et al., 2010, Camicia et al., 2014).
The role of NETs in pediatric infection is not well understood. We hypnotize that children are capable of forming NETs and that NETosis plays an important role in pediatric sepsis. This study is designed to assess the role of neutrophil extracellular traps (NETs) in neonatal and pediatric sepsis as well as to evaluate markers of NETs formation as early predictors of neonatal and pediatric sepsis.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Hamburg, Tyskland, 20246
- Rekruttering
- University Medical Center Hamburg-Eppendorf
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Kontakt:
- Michael C Boettcher, M.D.
- Telefonnummer: +4915222815153
- E-mail: m.boettcher@uke.de
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Hamburg, Tyskland, 22763
- Rekruttering
- Altona Children's Hospital
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Kontakt:
- Michael Boettcher, M.D.
- Telefonnummer: +4015222815153
- E-mail: m.boettcher@uke.de
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Signed informed consent by the parent or guardian of the patient
- Chronological age below 90 days (= neonatal branch) or below 18 years (pediatric branch)
- Suspicion of sepsis infection
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Actual Sepsis
For infants below 44 weeks inclusive of corrected age clinical sepsis is defined, according to the Expert Meeting on Neonatal and Pediatric Sepsis (Report on the Expert Meeting on Neonatal and Pediatric Sepsis - 8 June 2010, EMA London). Confirmed sepsis is defined as positive culture for pathogens in a sample from a normally sterile site and at least one laboratory sign or clinical sign (not shown) For children above 44 weeks corrected age clinical sepsis is defined according to the Goldstein criteria (Goldstein et al, 2005). Confirmed sepsis: positive culture for pathogens in a sample from a normally sterile site and at least one laboratory sign or clinical sign (not shown) |
i.e.
Plasma DNA, Histone, MPO, DNase
Andre navne:
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Suspected Sepsis
None of the above.
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i.e.
Plasma DNA, Histone, MPO, DNase
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Neutrophil Extracellular Traps
Tidsramme: 2 weeks
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Neutrophil Extracellular Traps are measured by serum markers
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2 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Sepsis
Tidsramme: 2 weeks
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Sepsis is defined according to the Goldstein criteria 2015.
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2 weeks
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PV4991 & PV5063
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Kliniske forsøg med Sepsis
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Assiut UniversityIkke rekrutterer endnuSepsis-induceret myokardiedysfunktion | Sepsis induceret kardiomyopatiEgypten
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University of Kansas Medical CenterUniversity of KansasRekrutteringSepsis | Septisk chok | Sepsis syndrom | Sepsis, svær | Sepsis bakteriel | Sepsis BakteriæmiForenede Stater
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Jip GroenInBiomeRekrutteringMikrobiel kolonisering | Neonatal infektion | Neonatal sepsis, tidligt opstået | Mikrobiel sygdom | Klinisk sepsis | Kultur Negativ Neonatal Sepsis | Neonatal sepsis, sent opstået | Kultur Positiv Neonatal SepsisHolland
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The University of QueenslandRoyal Brisbane and Women's HospitalUkendt
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Karolinska InstitutetÖrebro University, SwedenAfsluttetSepsis | Sepsis syndrom | Sepsis, sværSverige
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Ohio State UniversityAfsluttetSepsis, Svær Sepsis og Septisk ShockForenede Stater
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Indonesia UniversityAfsluttetAlvorlig sepsis med septisk stød | Alvorlig sepsis uden septisk stødIndonesien
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University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsAfsluttetSepsis | Septisk chok | Alvorlig sepsis | Sepsis syndromDet Forenede Kongerige
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Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityTilmelding efter invitationAlvorlig sepsis | Alvorlig sepsis uden septisk stødForenede Stater
Kliniske forsøg med Markers of NET formation
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Dublin City UniversityAfsluttetDepression | Selv koncept | Kropsfedtsammensætning | Opfattet social støtteIrland
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University of VirginiaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Afsluttet