- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01662375
A Prospective Study Evaluating the Feasibility and Ethical Perspective of Maastricht III Organ Procurement in French Intensive Care Unit Patients (MIII)
20. oktober 2014 opdateret af: Nantes University Hospital
The Maastricht III procedure consists of performing organ donation in patients in whom cardiac arrest is consecutive to a decision to withdraw life support.This MIII procedure is not applied in France, in contrast with other industrialized countries.The proposed study is designed to evaluate the feasibility of adapting the MIII procedure in France by conducting a single-centre, prospective study.
Within the population of patients admitted to the Nantes University Hospital Medical Intensive Care Unit for whom a clinical team meeting decides to withdraw life support, the investigators want to determine the delay elapsed between the life support withdrawing and the onset of spontaneous cardiac arrest, that is without any intentional procedure susceptible of precipitate the death onset.
The cardiovascular state observed during this period and its duration determine the viability of the organs harvested.
The invetigators also want to determine the incidence of refusal of organ donation that would be formulated by the family and/or loved ones if they had been asked to consent to an MIII procedure at the time of announcement of the clinical team's decision to withdraw life support.Anonymous data concerning the patient will be collected by using a predefined grid, completed partly by the medical team in charge of the patient and partly by a CRA from data in the patient's medical file.The study with families and/or loved ones will be conducted in the context of the CHU de NANTES Clinical Ethics Unit and according to this unit's methodology.
The main working tool used by the Clinical Ethics Unit consists of interviews between its members and the various parties participating in elaboration of a decision (in this case, the virtual possibility of organ donation according to the MIII procedure).The purpose of this interview is to stimulate reflection on issues not previously considered, by introducing new elements and by using, as a tool, the principles of biomedical ethics developed by Beauchamps and Childress.
This study should be able to determine which types of patients could be concerned by the Maastricht III procedure.
The expected results should help to define the quantitative impact and feasibility of this procedure on organ donation and could be used to subsequently propose a larger-scale multicenter prospective study.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
29
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Nantes, Frankrig, 44093
- CHU de Nantes
-
-
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
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
These are patients medical or surgical intensive care who are subject to a collective decision to stop intensive care treatments
Beskrivelse
Inclusion Criteria:
- patients eligible to life support withdrawing.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
MIII
|
The interventional nature of the study is justified by the need for particular monitoring of patients in whom life support is withdrawn following the clinical team's decision.
The questions posed to the patient's family and/or relatives, do not modify the care provided to the patient.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Delay between the withdrawal of intensive care and spontaneous cardiac arrest
Tidsramme: 1 day
|
1 day
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. august 2012
Primær færdiggørelse (Faktiske)
1. oktober 2013
Studieafslutning (Faktiske)
1. juli 2014
Datoer for studieregistrering
Først indsendt
3. august 2012
Først indsendt, der opfyldte QC-kriterier
7. august 2012
Først opslået (Skøn)
10. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. oktober 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. oktober 2014
Sidst verificeret
1. oktober 2014
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- RC12_0038
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 .