No interventtion
Otherto enhance the understanding of the factors associated with the number of organs retrieved from patients admitted to the ICU for organ donation
NCT Number: NCT06768515
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Hôpital Pitié Salpêtrière AP-HP, Paris, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
to enhance the understanding of the factors associated with the number of organs retrieved from patients admitted to the ICU for organ donation
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Mean arterial pressure (MAP) between 60 and 110 mmHg
Time frame: Within 7 last days before brain death and before multi-organ retrieval
Central venous pressure (CVP) between 4 and 12 mmHg
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Left ventricular ejection fraction (LVEF) ≥ 50%
Time frame: 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))
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Arterial pH between 7.3 and 7.5
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
PaO2/FiO2 ≥ 300
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Sodium levels ≤ 155 mmol/L
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Diuresis ≥ 0.5 mL/kg/h
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Blood glucose ≤ 1.5 g/L
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
The demographics of Brain dead
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Describe the causes of neurological injury leading to brain death
Time frame: 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
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Describe the incidence of organ failures before and after brain death
Time frame: 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
Time frame: 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
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Describe the incidence of diabetes insipidus
Time frame: Between admission to intensive care and brain death and before multi-organ retrieval
Describe the treatments administered before and after brain death
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
François DEPRET, MD
CONTACT
Maxime COUTROT, MD
CONTACT
Société Française d'Anesthésie et de Réanimation
Other
Acronym: DONOR-OBS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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