- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01155674
Innate Immune Functions of Immature Neutrophils
1. juli 2010 oppdatert av: University Hospital, Geneva
Polymorphonuclear neutrophils, or granulocytes, are essential effector cells of the innate immune system against bacterial infections.
Their role in sepsis has been long established as the primary phagocyte to clear the infectious process.
In the early phase of sepsis, one observes a massive recruitment of immature neutrophils from the bone marrow into peripheral blood, the so-called "band forms" or "left shift cells".
Despite the daily clinical use of neutrophil band forms count in the care of septic patients and their abundance in septic blood, no information exists on the fate of these cells, nor on their capacity to mount an efficient innate immune response.
It is the goal of this proposal to study the fate and the innate immune functions of immature neutrophils obtained in patients with early septic shock.
Immature neutrophils will be separated from mature neutrophils.
The following functions will be studied ex vivo in mature vs. immature neutrophils from a series of patients with severe sepsis and septic shock: (1) surface expression of receptors of the innate immunity; (2) production of inflammatory mediators and reactive oxygen species in response to bacterial agonists; (3) chemotaxis; (4) phagocytosis of Gram-positive and Gram-negative bacteria; and (5) ex vivo viability (life span) and resistance to apoptosis.
Importantly, the investigators have developed and mastered all in vitro assays and cell separation techniques necessary to address and answer these important questions.
This project will undoubtedly shed light on the fate and function of a prominent leukocyte population circulating in patients with severe bacterial infections and sepsis.
Studieoversikt
Detaljert beskrivelse
Objectives
- Primary objective: To determine the innate immune functions of immature neutrophils in comparison to those from mature neutrophils, sampled from patients with severe sepsis and sepsis shock and in control patients (trauma patients and healthy donors (only mature neutrophils in the latter case)
- Secondary objectives: To determine the fate and span life of immature neutrophils in comparison to mature neutrophils, sampled from patients with severe sepsis and sepsis shock and in control patients (trauma patients and healthy donors (only mature neutrophils in the latter case).
Inclusion criteria
- Patients with severe sepsis or septic shock (according to ACCP/FCCM standard definitions) with > 5% immature neutrophils.
- Patients with a noninfectious systemic inflammatory response syndrome (SIRS), e.g. patients with head trauma or multiple trauma with > 5% immature neutrophils.
- Healthy donors
Exclusion criteria
- Severe immunosuppression (e.g. HIV with < 200 CD4/mm3), treatment with glucocorticoids (> 300 mg hydrocortisone/day) or other immunosuppressive therapy
- Neutropenia (neutrophils < 0.5 G/l).
- Recent chemotherapy or administration of intravenous immunoglobulins within the last 4 weeks.
Endpoints
- Surface expression of receptors of the innate immunity in immature vs. mature neutrophils.
- Production by immature vs. mature neutrophils of inflammatory mediators and reactive oxygen species in response to bacterial agonists.
- Chemotaxis of immature vs. mature neutrophils.
- Phagocytosis of Gram-positive and Gram-negative bacteria by immature vs. mature neutrophils.
- Ex vivo viability and resistance to apoptosis of immature vs. mature neutrophils.
Studietype
Observasjonsmessig
Registrering (Forventet)
60
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Geneva, Sveits, 1211
- Rekruttering
- University Hospitals of Geneva, Intensive Care
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Ta kontakt med:
- Jerome Pugin, MD
- E-post: jerome.pugin@unige.ch
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Underetterforsker:
- Geneviève Drifte, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
- Patients with severe sepsis or septic shock
- Patients with a noninfectious systemic inflammatory response syndrome (SIRS)
- Healthy donors
Beskrivelse
Inclusion Criteria:
- Patients with severe sepsis or septic shock (according to ACCP/FCCM standard definitions) with > 5% immature neutrophils.
- Patients with a noninfectious systemic inflammatory response syndrome (SIRS), e.g. patients with head trauma or multiple trauma with > 5% immature neutrophils.
- Healthy donors
Exclusion Criteria:
- Severe immunosuppression (e.g. HIV with < 200 CD4/mm3), treatment with glucocorticoids (> 300 mg hydrocortisone/day) or other immunosuppressive therapy
- Neutropenia (neutrophils < 0.5 G/l).
- Recent chemotherapy or administration of intravenous immunoglobulins within the last 4 weeks.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Sepsis patients
Patients presenting sepsis
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SIRS patients
Patients presenting with the systemic inflammatory response syndrome
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Healthy subjects
Healthy blood donors
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Innate immune functions of neutrophils
Tidsramme: 12 months
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12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2010
Primær fullføring (Forventet)
1. august 2011
Studiet fullført (Forventet)
1. oktober 2011
Datoer for studieregistrering
Først innsendt
1. juli 2010
Først innsendt som oppfylte QC-kriteriene
1. juli 2010
Først lagt ut (Anslag)
2. juli 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
2. juli 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. juli 2010
Sist bekreftet
1. februar 2010
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CER 09-311
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