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

Condition(s) studied

Investigational drug(s) / intervention(s)

No interventtion: to enhance the understanding of the factors associated with the number of organs retrieved from patients admitted to the ICU for organ donation

Study summary

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

Primary outcome measure(s)

• Mean arterial pressure — Between admission to intensive care and brain death and before multi-organ retrieval
  Mean arterial pressure (MAP) between 60 and 110 mmHg
• Central venous pressure — Within 7 last days before brain death and before multi-organ retrieval
  Central venous pressure (CVP) between 4 and 12 mmHg
• Left ventricular ejection fraction — Between admission to intensive care and brain death and before multi-organ retrieval
  Left ventricular ejection fraction (LVEF) ≥ 50%
• vasopressor — Between admission to intensive care and brain death and before multi-organ retrieval
  Low doses and a single vasopressor. (≤10 µg/kg/min of dopamine or ≤60 µg/min of Neosynephrine or ≤10 µg/min of norepinephrine))
• Arterial pH — Between admission to intensive care and brain death and before multi-organ retrieval
  Arterial pH between 7.3 and 7.5
• PaO2/FiO2 — Between admission to intensive care and brain death and before multi-organ retrieval
  PaO2/FiO2 ≥ 300
• Sodium levels — Between admission to intensive care and brain death and before multi-organ retrieval
  Sodium levels ≤ 155 mmol/L
• Diuresis — Between admission to intensive care and brain death and before multi-organ retrieval
  Diuresis ≥ 0.5 mL/kg/h
• Blood glucose — Between admission to intensive care and brain death and before multi-organ retrieval
  Blood glucose ≤ 1.5 g/L

Trial sites (2)

More Société Française d'Anesthésie et de Réanimation trials in France

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