ICU Management of Brain-Dead Donors Before Multi-Organ Procurement and Factors Associated With the Number of Organs Retrieved

ConditionDeath, Brain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSociété Française d'Anesthésie et de Réanimation

About this trial

Solid organ transplantation is the treatment of choice for end stage organ failure to improve patients' quality of life and survival. Each year, more than 5,000 solid organ transplants are performed in France, mainly from brain death donors (BDD).

Approximately 1,500 BDD donors have one or more organs removed each year. Despite the growing demand for transplanted organs, the number of organs available from deceased donors has remained stable over the past few decades. This highlights the need to optimize the management of potential BDD, in order to increase both the quality and number of transplanted organs. Several studies have found an association between the characteristics and management of BDD donors and the number of organs, or even the function of transplanted organs. Data suggest that hemodynamic, respiratory, and metabolic therapeutic targets during BDD management prior to multi-organ procurement were associated with a higher number of transplanted organs compared to standard care. However, this has never been confirmed in a French population. Furthermore, while the impact of these therapeutic goals has been studied after the donor is in a state of brain death, the events occurring in the ICU before reaching brain death status and their impact on the number of organs retrieved have not been investigated. Lastly, the intensity of the therapeutic interventions used to achieve these goals, and certain management delays, have only been partially studied.

Our hypothesis is that achieving a bundle of therapeutic goals, and the intensity of the interventions used to reach these goals, both before and after BDD, are associated with a greater number of organs retrieved.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over 18 years of age, hospitalized in the ICU

In a state of brain death

No objection to organ donation during their lifetime

Patients with social security coverage

Disqualifiers

Objection to the use of their data during their lifetime

Registration in the national refusal registry

Trial population

Patients in a state of brain dead. Patients meeting the inclusion criteria from January 1, 2022, to December 31, 2024, will be included in the study.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • No interventtion

    Other intervention

    to enhance the understanding of the factors associated with the number of organs retrieved from patients admitted to the ICU for organ donation

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Organ donation1 intervention

Trial outcomes

Primary outcomes

1

Mean arterial pressure

Mean arterial pressure (MAP) between 60 and 110 mmHg

Time frame
Between admission to intensive care and brain death and before multi-organ retrieval
2

Central venous pressure

Central venous pressure (CVP) between 4 and 12 mmHg

Time frame
Within 7 last days before brain death and before multi-organ retrieval
3

Left ventricular ejection fraction

Left ventricular ejection fraction (LVEF) ≥ 50%

Time frame
Between admission to intensive care and brain death and before multi-organ retrieval
4

vasopressor

Low doses and a single vasopressor. (≤10 µg/kg/min of dopamine or ≤60 µg/min of Neosynephrine or ≤10 µg/min of norepinephrine))

Time frame
Between admission to intensive care and brain death and before multi-organ retrieval

Secondary outcomes

1

demographics of Brain dead

The demographics of Brain dead

Time frame
Between admission to intensive care and brain death and before multi-organ retrieval
2

Causes of neurological injury leading to brain death

Describe the causes of neurological injury leading to brain death

Time frame
Between admission to intensive care and brain death and before multi-organ retrieval
3

Timelines and durations of patient management before and after brain death

Descibe the timelines and durations of patient management before and after brain death

Time frame
Between admission to intensive care and brain death and before multi-organ retrieval
4

Incidence of organ failures before and after brain death

Describe the incidence of organ failures before and after brain death

Time frame
Between admission to intensive care and brain death and before multi-organ retrieval

Other outcomes

Sponsors and contacts

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