A Prospective Study Evaluating the Feasibility and Ethical Perspective of Maastricht III Organ Procurement in French Intensive Care Unit Patients (MIII)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01662375
First received: August 3, 2012
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Intensive Care
Supportive Care
Withdrawal of Life Support
Other: Surveillance and interview

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Delay between the withdrawal of intensive care and spontaneous cardiac arrest [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MIII Other: Surveillance and interview
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

These are patients medical or surgical intensive care who are subject to a collective decision to stop intensive care treatments

Criteria

Inclusion Criteria:

  • patients eligible to life support withdrawing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662375

Contacts
Contact: Daniel VILLERS (0)2 40 08 73 60 ext +33 daniel.villers@chu-nantes.fr

Locations
France
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Daniel Villers    (0)2 40 08 73 60 ext +33    daniel.villers@chu-nantes.fr   
Principal Investigator: Daniel Villers         
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01662375     History of Changes
Other Study ID Numbers: RC12_0038
Study First Received: August 3, 2012
Last Updated: April 29, 2014
Health Authority: France: Committee for the Protection of Personnes

ClinicalTrials.gov processed this record on September 30, 2014