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Effects of Preconditioning With Sevoflurane During Organ Procurement From Brain Dead Donors: Impact on Early Function of Liver Allografts

20. januar 2015 opdateret af: Gregory Minguet, University of Liege
The aim of the investigators study is to investigate the effects of anaesthetic preconditioning with sevoflurane during organs harvesting in brain dead donors. More particularly, the investigators will investigate whether sevoflurane preconditioning protects against ischaemia-reperfusion the livers and kidneys allografts after a prolonged period of cold ischaemia and whether this protection translates in a better clinical functional recovery of these allografts.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

240

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Liège, Belgien, B-4000
        • Department of Anesthesiology, CHU Liège

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • all consecutive brain dead donors in the Belgian university hospitals of Leuven, Brussels, Louvain and Liège eligible for organs harvesting followed by organs transplantation in the Eurotransplant area. There is no age limitation for eligibility

Exclusion Criteria:

  • haemodynamic instability that precludes safe administration of 2% sevoflurane.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Sevoflurane
1 MAC of sevoflurane for 15 minutes before organs procurement.
Medicin: Sevoflurane
In the sevoflurane group, the anesthetic agent has to be administered immediately after arrival in the operating room to reach an end-expiratory target concentration of 2%. This concentration of sevoflurane should be maintained until the procedural cardiac arrest and for at least 15 min.
Ingen indgriben: No intervention
No volatile anesthetics during organs procurement

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite outcome of liver function following liver transplantation.
Tidsramme: First week post-transplantation
  • Transaminases, bilirubin, prothrombin time (PT) and international normalized ratio (INR) on the first post-transplantation blood test and on the following samples from the 1st to the 7th postoperative days.

  • Number of liver recipients that will meet the criteria for "early allograft dysfunction" as defined by :

    • bilirubin ≥10 mg/dL on the 7th day.
    • INR ≥ 1.6 on the 7th day.
    • ALAT or ASAT > 2000 UI/L during the first 7 postoperative days.
First week post-transplantation

Sekundære resultatmål

Resultatmål
Tidsramme
• Incidence of primary non function (liver failure requiring emergent re-transplantation)
Tidsramme: 30-day and 6-month after transplantation.
30-day and 6-month after transplantation.
• Hospital length of stay.
Tidsramme: 30-day and 6-month after transplantation.
30-day and 6-month after transplantation.
• Allograft function (yes/no) at 30-day and 6-month after transplantation.
Tidsramme: 30-day and 6-month after transplantation.
30-day and 6-month after transplantation.
• Hospital mortality and at 30-day.
Tidsramme: 30-day.
30-day.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite outcome of post transplantation kidney function.
Tidsramme: First week after transplantation, 30 day and 6-month.
• Creatinine on the first post-transplantation blood test and on the following samples from the first to the 7th postoperative days. Maximal creatinine values and values at 72-hour after transplantation, the time for 50% decline, and the area under the curve during the first postoperative week.
First week after transplantation, 30 day and 6-month.
• Delayed graft function : (defined as dialysis during first postop wk; decline in creatinine value
Tidsramme: First week after transplantation, 30 day and 6-month.
  • Dialysis during the first postoperative week.
  • Decline in creatinine value of less than 10% per day during 3 consecutive days.
First week after transplantation, 30 day and 6-month.
• Length of delayed graft function.
Tidsramme: First week after transplantation, 30 day and 6-month.
First week after transplantation, 30 day and 6-month.
• Primary non function (patient who must go back to chronic hemodialysis and must be listed for re-transplantation
Tidsramme: First week after transplantation, 30 day and 6-month.
patient who must go back to chronic hemodialysis and must be listed for re-transplantation, at 30-day and 6-month after transplantation.
First week after transplantation, 30 day and 6-month.
• Hospital length of stay.
Tidsramme: First week after transplantation, 30 day and 6-month.
First week after transplantation, 30 day and 6-month.
• Hospital mortality and mortality at 30-day.
Tidsramme: First week after transplantation, 30 day and 6-month.
First week after transplantation, 30 day and 6-month.

Samarbejdspartnere og efterforskere

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

Sponsor

University of Liege

Efterforskere

  • Ledende efterforsker: Jean L Joris, MD, PhD, CHU Liège - Belgium

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. januar 2015

Primær færdiggørelse (Forventet)

1. december 2017

Datoer for studieregistrering

Først indsendt

26. juni 2014

Først indsendt, der opfyldte QC-kriterier

16. januar 2015

Først opslået (Skøn)

19. januar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. januar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. januar 2015

Sidst verificeret

1. januar 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2014-26-06

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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