ICU Management of Brain-Dead Donors Before Multi-Organ Procurement and Factors Associated With the Number of Organs Retrieved
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Mean arterial pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Objection to the use of their data during their lifetime
- •Registration in the national refusal registry
结局指标
主要结局
Mean arterial pressure
时间窗: 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
时间窗: 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
时间窗: Between admission to intensive care and brain death and before multi-organ retrieval
Left ventricular ejection fraction (LVEF) ≥ 50%
vasopressor
时间窗: 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
时间窗: Between admission to intensive care and brain death and before multi-organ retrieval
Arterial pH between 7.3 and 7.5
PaO2/FiO2
时间窗: Between admission to intensive care and brain death and before multi-organ retrieval
PaO2/FiO2 ≥ 300
Sodium levels
时间窗: Between admission to intensive care and brain death and before multi-organ retrieval
Sodium levels ≤ 155 mmol/L
Diuresis
时间窗: Between admission to intensive care and brain death and before multi-organ retrieval
Diuresis ≥ 0.5 mL/kg/h
Blood glucose
时间窗: Between admission to intensive care and brain death and before multi-organ retrieval
Blood glucose ≤ 1.5 g/L
次要结局
- demographics of Brain dead(Between admission to intensive care and brain death and before multi-organ retrieval)
- Causes of neurological injury leading to brain death(Between admission to intensive care and brain death and before multi-organ retrieval)
- Timelines and durations of patient management before and after brain death(Between admission to intensive care and brain death and before multi-organ retrieval)
- Incidence of organ failures before and after brain death(Between admission to intensive care and brain death and before multi-organ retrieval)
- Incidence of acute kidney failure before and after brain death(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(Between admission to intensive care and brain death and before multi-organ retrieval)
- Incidence of diabetes insipidus(Between admission to intensive care and brain death and before multi-organ retrieval)
- Treatments administered before and after brain death(Between admission to intensive care and brain death and before multi-organ retrieval)
- Number and nature of organs retrieved(Between admission to intensive care and brain death and before multi-organ retrieval)
- Number and nature of organs available for transplantation(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(Between admission to intensive care and brain death and before multi-organ retrieval)
- Number, causes, and associated factors of unsuccessful organ retrieval procedures(Between admission to intensive care and brain death and before multi-organ retrieval)