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

Recruiting

• Conditions: Death, Brain

• Registration Number: NCT06768515
• Lead Sponsor: Société Française d'Anesthésie et de Réanimation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2025-01-06
• Study First Posted: 2025-01-10
• Study Start: 2025-04-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-02-15
• Study Completion: 2026-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
demographics of Brain dead	Between admission to intensive care and brain death and before multi-organ retrieval	The demographics of Brain dead
Causes of neurological injury leading to brain death	Between admission to intensive care and brain death and before multi-organ retrieval	Describe the causes of neurological injury leading to brain death
Timelines and durations of patient management before and after brain death	Between admission to intensive care and brain death and before multi-organ retrieval	Descibe the timelines and durations of patient management before and after brain death
Incidence of organ failures before and after brain death	Between admission to intensive care and brain death and before multi-organ retrieval	Describe the incidence of organ failures before and after brain death
Incidence of acute kidney failure before and after brain death	Between admission to intensive care and brain death and before multi-organ retrieval	Describe the incidence of acute kidney failure before and after brain death
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	Describe the incidence of infections, sepsis, and septic shock before and after brain death
Incidence of diabetes insipidus	Between admission to intensive care and brain death and before multi-organ retrieval	Describe the incidence of diabetes insipidus
Treatments administered before and after brain death	Between admission to intensive care and brain death and before multi-organ retrieval	Describe the treatments administered before and after brain death
Number and nature of organs retrieved	Between admission to intensive care and brain death and before multi-organ retrieval	Describe the number and nature of organs retrieved, including heart, lungs (2 organs), kidneys (2 organs), liver, pancreas
Number and nature of organs available for transplantation	Between admission to intensive care and brain death and before multi-organ retrieval	Describe the number and nature of organs available for transplantation, including heart, lungs (2 organs), kidneys (2 organs), liver, pancreas
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	Describe the number of organs placed on ex situ preservation and the type of preservation method used
Number, causes, and associated factors of unsuccessful organ retrieval procedures	Between admission to intensive care and brain death and before multi-organ retrieval	Desctibe the number, causes, and associated factors of unsuccessful organ retrieval procedures

Trial Locations

Locations (2)

Hôpital Saint-Louis, AP-HP; 🇫🇷 Paris, France

Hôpital Pitié Salpêtrière AP-HP; 🇫🇷 Paris, France