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The Complement Lectin Pathway After Cardiac Arrest

4. juli 2016 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

82

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Aarhus, Danmark, 8000
        • Department of Biomedicine, Aarhus University
      • Aarhus, Danmark, 8200
        • Department of Anesthesiology and Intensive Care, Aarhus University Hospital
      • Aarhus, Danmark, 8200
        • Department of Clinical Biochemistry, Aarhus University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
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)
Andet: Targeted temperature management (33 degree Celsius)
Eksperimentel: 48 hour of targeted temperature management
Patients resuscitated after cardiac arrest and treated with 48 hours of targeted temperature management (33 degree Celsius)
Andet: Targeted temperature management (33 degree Celsius)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
MASP-2 concentration in plasma
Tidsramme: 48 hours
48 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MASP-2 concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
24 hours, 48 hours and 72 hours
MASP-2 concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
MASP-2 concentration in plasma compared with 30-day mortality
24 hours, 48 hours, 72 hours
MASP-2 concentration in plasma
Tidsramme: 24 hours to 72 hours
24 hours to 72 hours
MASP-1 concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
24 hours, 48 hours and 72 hours
MASP-1 concentration in plasma
Tidsramme: 24 hours to 72 hours
24 hours to 72 hours
MASP-1 concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
MASP-1 concentration in plasma compared with 30-day mortality
24 hours, 48 hours, 72 hours
MASP-3 concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
24 hours, 48 hours and 72 hours
MASP-3 concentration in plasma
Tidsramme: 24 hours to 72 hours
24 hours to 72 hours
MASP-3 concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
MASP-3 concentration in plasma compared with 30-day mortality
24 hours, 48 hours, 72 hours
Mannan-Binding-Lectin concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
24 hours, 48 hours and 72 hours
Mannan-Binding-Lectin concentration in plasma
Tidsramme: 24 hours to 72 hours
24 hours to 72 hours
Mannan-Binding-Lectin concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
Mannan-Binding-Lectin concentration in plasma compared to 30-day mortality
24 hours, 48 hours, 72 hours
MAp44 concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
24 hours, 48 hours and 72 hours
Map44 concentration in plasma
Tidsramme: 24 hours to 72 hours
24 hours to 72 hours
MAp44 concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
MAp44 concentration in plasma compared with 30-day mortality
24 hours, 48 hours, 72 hours
MAp19 concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
24 hours, 48 hours and 72 hours
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
24 hours, 48 hours and 72 hours
H-ficolin concentration in plasma
Tidsramme: 24 hours to 72 hours
24 hours to 72 hours
H-ficolin concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
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
24 hours, 48 hours and 72 hours
M-ficolin concentration in plasma
Tidsramme: 24 hours to 72 hours
24 hours to 72 hours
M-ficolin concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
M-ficolin concentration in plasma compared with 30-day mortality
24 hours, 48 hours, 72 hours
CL-L1 concentration in plasma
Tidsramme: 24 hours, 48 hours and 72 hours
24 hours, 48 hours and 72 hours
CL-L1 concentration in plasma
Tidsramme: 24 hours to 72 hours
24 hours to 72 hours
CL-L1 concentration in plasma
Tidsramme: 24 hours, 48 hours, 72 hours
CL-L1 concentration in plasma compared with 30-day mortality
24 hours, 48 hours, 72 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Aarhus

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2016

Primær færdiggørelse (Forventet)

1. juli 2016

Studieafslutning (Forventet)

1. juli 2017

Datoer for studieregistrering

Først indsendt

16. juni 2016

Først indsendt, der opfyldte QC-kriterier

4. juli 2016

Først opslået (Skøn)

7. juli 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juli 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12345 (Danish Center for Healthcare Improvements)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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