The Complement Lectin Pathway After Cardiac Arrest
4. juli 2016 oppdatert av: University of Aarhus
The Complement Lectin Pathway in Patients Resuscitated After Cardiac Arrest
This study includes comatose survivors of out-of-hospital cardiac arrest treated with 24 hours or 48 hours of targeted temperature management.
The overall aim is to evaluate the importance of plasma complement protein concentrations in patients resuscitated after out-of-hospital cardiac arrest and treated with 24 hours or 48 hours of targeted temperature management.
The specific aim is to evaluate:
- the concentration of plasma lectin pathway proteins the first, second and third day after cardiac arrest
- the relation between concentration of plasma lectin pathway proteins and mortality
- if prolonged targeted temperature management influences the concentration of plasma lectin pathway proteins
This study is a sub-study to the trial entitled: "Time-differentiated targeted temperature management (TTH48) (ClinicalTrials.gov Identifier: NCT01689077)"
The following Complement Lectin Pathway proteins will be measured: Mannan-Binding-Lectin, M-ficolin, H-ficolin, CL-L1, MASP-1, MASP-2, MASP-3, MAp19 and MAp44.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
82
Fase
- Ikke aktuelt
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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Aarhus, Danmark, 8000
- Department of Biomedicine, Aarhus University
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Aarhus, Danmark, 8200
- Department of Anesthesiology and Intensive Care, Aarhus University Hospital
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Aarhus, Danmark, 8200
- Department of Clinical Biochemistry, Aarhus University Hospital
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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 til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Out-of-Hospital Cardiac Arrest of presumed cardiac cause
- Return of spontaneous circulation (ROSC)
- Glasgow Coma Score < 8
- Age > 18 years and < 80 years
Exclusion Criteria:
- > 60 minutes from the circulatory collapse to ROSC
- Time interval > 4 hours from cardiac arrest to initiation of targeted temperature management
- Terminal illness
- Coagulation disorder
- Unwitnessed asystolia
- Cerebral performance category 3-4 before the cardiac arrest
- Severe persistent cardiogenic shock
- Pregnancy
- Persistent cardiogenic shock (systolic bloodpressure < 80 despite inotropic treatment)
- New apoplexy or cerebral hemorrhage
- Lack of consent from the relatives
- Lack of consent from the general practitioner
- Lack of consent from the patient
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 24 hour of targeted temperature management
Patients resuscitated after cardiac arrest and treated with 24 hours of targeted temperature management (33 degree Celsius)
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Eksperimentell: 48 hour of targeted temperature management
Patients resuscitated after cardiac arrest and treated with 48 hours of targeted temperature management (33 degree Celsius)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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MASP-2 concentration in plasma
Tidsramme: 48 hours
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48 hours
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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MASP-2 concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
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MASP-2 concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
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MASP-2 concentration in plasma compared with 30-day mortality
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24 hours, 48 hours, 72 hours
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MASP-2 concentration in plasma
Tidsramme: 24 hours to 72 hours
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24 hours to 72 hours
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MASP-1 concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
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MASP-1 concentration in plasma
Tidsramme: 24 hours to 72 hours
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24 hours to 72 hours
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MASP-1 concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
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MASP-1 concentration in plasma compared with 30-day mortality
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24 hours, 48 hours, 72 hours
|
|
MASP-3 concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
|
|
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MASP-3 concentration in plasma
Tidsramme: 24 hours to 72 hours
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24 hours to 72 hours
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MASP-3 concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
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MASP-3 concentration in plasma compared with 30-day mortality
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24 hours, 48 hours, 72 hours
|
|
Mannan-Binding-Lectin concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
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Mannan-Binding-Lectin concentration in plasma
Tidsramme: 24 hours to 72 hours
|
24 hours to 72 hours
|
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Mannan-Binding-Lectin concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
|
Mannan-Binding-Lectin concentration in plasma compared to 30-day mortality
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24 hours, 48 hours, 72 hours
|
|
MAp44 concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
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Map44 concentration in plasma
Tidsramme: 24 hours to 72 hours
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24 hours to 72 hours
|
|
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MAp44 concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
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MAp44 concentration in plasma compared with 30-day mortality
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24 hours, 48 hours, 72 hours
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|
MAp19 concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
|
24 hours, 48 hours and 72 hours
|
|
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MAp19 concentration in plasma
Tidsramme: 24 hours to 72 hours
|
24 hours to 72 hours
|
|
|
MAp19 concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
|
MAp19 concentration in plasma compared with 30-day mortality
|
24 hours, 48 hours, 72 hours
|
|
H-ficolin concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
|
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H-ficolin concentration in plasma
Tidsramme: 24 hours to 72 hours
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24 hours to 72 hours
|
|
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H-ficolin concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
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H-ficolin concentration in plasma compared with 30-day mortality
|
24 hours, 48 hours, 72 hours
|
|
M-ficolin concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
|
|
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M-ficolin concentration in plasma
Tidsramme: 24 hours to 72 hours
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24 hours to 72 hours
|
|
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M-ficolin concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
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M-ficolin concentration in plasma compared with 30-day mortality
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24 hours, 48 hours, 72 hours
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CL-L1 concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
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CL-L1 concentration in plasma
Tidsramme: 24 hours to 72 hours
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24 hours to 72 hours
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CL-L1 concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
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CL-L1 concentration in plasma compared with 30-day mortality
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24 hours, 48 hours, 72 hours
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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. februar 2016
Primær fullføring (Forventet)
1. juli 2016
Studiet fullført (Forventet)
1. juli 2017
Datoer for studieregistrering
Først innsendt
16. juni 2016
Først innsendt som oppfylte QC-kriteriene
4. juli 2016
Først lagt ut (Anslag)
7. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
7. juli 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. juli 2016
Sist bekreftet
1. juni 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 12345 (Danish Center for Healthcare Improvements)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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