Clinical trial NCT06768515: ICU Management of Brain-Dead Donors Before Multi-Organ Procurement and Factors Associated With the Number of Organs Retrieved
Official title: ICU Management of Brain-Dead Donors Before Multi-Organ Procurement and Factors Associated With the Number of Organs Retrieved
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Death, Brain
Lead sponsor: Société Française d'Anesthésie et de Réanimation
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Objection to the use of their data during their lifetime
* Registration in the national refusal registry

Primary outcomes:
measure: Mean arterial pressure
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Central venous pressure
timeFrame: Within 7 last days before brain death and before multi-organ retrieval
measure: Left ventricular ejection fraction
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: vasopressor
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Arterial pH
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: PaO2/FiO2
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Sodium levels
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Diuresis
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Blood glucose
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
Secondary outcomes:
measure: demographics of Brain dead
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Causes of neurological injury leading to brain death
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Timelines and durations of patient management before and after brain death
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Incidence of organ failures before and after brain death
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Incidence of acute kidney failure before and after brain death
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Incidence of infections, sepsis, and septic shock before and after brain death
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Incidence of diabetes insipidus
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Treatments administered before and after brain death
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Number and nature of organs retrieved
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Number and nature of organs available for transplantation
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Number of organs placed on ex situ preservation and the type of preservation method used
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
measure: Number, causes, and associated factors of unsuccessful organ retrieval procedures
timeFrame: Between admission to intensive care and brain death and before multi-organ retrieval
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Louis, AP-HP
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière AP-HP
Study officials:
References:
citation: Malinoski DJ, Patel MS, Daly MC, Oley-Graybill C, Salim A; UNOS Region 5 DMG workgroup. The impact of meeting donor management goals on the number of organs transplanted per donor: results from the United Network for Organ Sharing Region 5 prospective donor management goals study. Crit Care Med. 2012 Oct;40(10):2773-80. doi: 10.1097/CCM.0b013e31825b252a.
citation: Oniscu GC, Rockell K, Martin DE. Challenges in undertaking research in transplantation. Lancet. 2025 Mar 1;405(10480):681-683. doi: 10.1016/S0140-6736(24)00931-0. Epub 2024 May 21. No abstract available.
citation: iomedecine, P. Chiffres 2022 de l'activité de prélèvement et de greffe d'organes et de tissus et Baromète 2023 sur la connaissance et la perception du don d'organes en France.
citation: Patel MS, De La Cruz S, Sally MB, Groat T, Malinoski DJ. Active Donor Management During the Hospital Phase of Care Is Associated with More Organs Transplanted per Donor. J Am Coll Surg. 2017 Oct;225(4):525-531. doi: 10.1016/j.jamcollsurg.2017.06.014. Epub 2017 Jul 21.
citation: Bera KD, Shah A, English MR, Harvey D, Ploeg RJ. Optimisation of the organ donor and effects on transplanted organs: a narrative review on current practice and future directions. Anaesthesia. 2020 Sep;75(9):1191-1204. doi: 10.1111/anae.15037. Epub 2020 May 19.
citation: Patel MS, Zatarain J, De La Cruz S, Sally MB, Ewing T, Crutchfield M, Enestvedt CK, Malinoski DJ. The impact of meeting donor management goals on the number of organs transplanted per expanded criteria donor: a prospective study from the UNOS Region 5 Donor Management Goals Workgroup. JAMA Surg. 2014 Sep;149(9):969-75. doi: 10.1001/jamasurg.2014.967.