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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Mean arterial pressure [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Central venous pressure [Срок оценки: Within 7 last days before brain death and before multi-organ retrieval]
• Left ventricular ejection fraction [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• vasopressor [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Arterial pH [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• PaO2/FiO2 [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Sodium levels [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Diuresis [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Blood glucose [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]

Вторичные конечные точки (12)

• demographics of Brain dead [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Causes of neurological injury leading to brain death [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Timelines and durations of patient management before and after brain death [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Incidence of organ failures before and after brain death [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Incidence of acute kidney failure before and after brain death [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Incidence of infections, sepsis, and septic shock before and after brain death [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Incidence of diabetes insipidus [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Treatments administered before and after brain death [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Number and nature of organs retrieved [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Number and nature of organs available for transplantation [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Number of organs placed on ex situ preservation and the type of preservation method used [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]
• Number, causes, and associated factors of unsuccessful organ retrieval procedures [Срок оценки: Between admission to intensive care and brain death and before multi-organ retrieval]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 2 центра

• Hôpital Saint-Louis, AP-HP — Paris
• Hôpital Pitié Salpêtrière AP-HP — Paris

Публикации

• 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. PMID 22846779
• 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. PMID 38788740
• 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.
• 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. PMID 28739153
• 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. PMID 32430910
• 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. PMID 25054379

Идентификаторы

NCT: NCT06768515 · 2024-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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