Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06768515
Acronym
DONOR-OBS
Enrollment
1000
Registered
2025-01-10
Start date
2025-04-23
Completion date
2026-02-15
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Death, Brain

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.

Interventions

OTHERNo interventtion

to enhance the understanding of the factors associated with the number of organs retrieved from patients admitted to the ICU for organ donation

Sponsors

Société Française d'Anesthésie et de Réanimation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Arterial pHBetween admission to intensive care and brain death and before multi-organ retrievalArterial pH between 7.3 and 7.5
PaO2/FiO2Between admission to intensive care and brain death and before multi-organ retrievalPaO2/FiO2 ≥ 300
Central venous pressureWithin 7 last days before brain death and before multi-organ retrievalCentral venous pressure (CVP) between 4 and 12 mmHg
Left ventricular ejection fractionBetween admission to intensive care and brain death and before multi-organ retrievalLeft ventricular ejection fraction (LVEF) ≥ 50%
Sodium levelsBetween admission to intensive care and brain death and before multi-organ retrievalSodium levels ≤ 155 mmol/L
vasopressorBetween admission to intensive care and brain death and before multi-organ retrievalLow doses and a single vasopressor. (≤10 µg/kg/min of dopamine or ≤60 µg/min of Neosynephrine or ≤10 µg/min of norepinephrine))
Mean arterial pressureBetween admission to intensive care and brain death and before multi-organ retrievalMean arterial pressure (MAP) between 60 and 110 mmHg
DiuresisBetween admission to intensive care and brain death and before multi-organ retrievalDiuresis ≥ 0.5 mL/kg/h
Blood glucoseBetween admission to intensive care and brain death and before multi-organ retrievalBlood glucose ≤ 1.5 g/L

Secondary

MeasureTime frameDescription
Number and nature of organs retrievedBetween admission to intensive care and brain death and before multi-organ retrievalDescribe the number and nature of organs retrieved, including heart, lungs (2 organs), kidneys (2 organs), liver, pancreas
Number, causes, and associated factors of unsuccessful organ retrieval proceduresBetween admission to intensive care and brain death and before multi-organ retrievalDesctibe the number, causes, and associated factors of unsuccessful organ retrieval procedures
Number of organs placed on ex situ preservation and the type of preservation method usedBetween admission to intensive care and brain death and before multi-organ retrievalDescribe the number of organs placed on ex situ preservation and the type of preservation method used
Number and nature of organs available for transplantationBetween admission to intensive care and brain death and before multi-organ retrievalDescribe the number and nature of organs available for transplantation, including heart, lungs (2 organs), kidneys (2 organs), liver, pancreas
demographics of Brain deadBetween admission to intensive care and brain death and before multi-organ retrievalThe demographics of Brain dead
Causes of neurological injury leading to brain deathBetween admission to intensive care and brain death and before multi-organ retrievalDescribe the causes of neurological injury leading to brain death
Timelines and durations of patient management before and after brain deathBetween admission to intensive care and brain death and before multi-organ retrievalDescibe the timelines and durations of patient management before and after brain death
Incidence of organ failures before and after brain deathBetween admission to intensive care and brain death and before multi-organ retrievalDescribe the incidence of organ failures before and after brain death
Incidence of acute kidney failure before and after brain deathBetween admission to intensive care and brain death and before multi-organ retrievalDescribe the incidence of acute kidney failure before and after brain death
Incidence of infections, sepsis, and septic shock before and after brain deathBetween admission to intensive care and brain death and before multi-organ retrievalDescribe the incidence of infections, sepsis, and septic shock before and after brain death
Incidence of diabetes insipidusBetween admission to intensive care and brain death and before multi-organ retrievalDescribe the incidence of diabetes insipidus
Treatments administered before and after brain deathBetween admission to intensive care and brain death and before multi-organ retrievalDescribe the treatments administered before and after brain death

Countries

France

Contacts

Primary ContactMaxime COUTROT, MD
maxime.coutrot@aphp.fr+33 1 42 49 93 94
Backup ContactFrançois DEPRET, MD
francois.depret@aphp.fr+33 1 42 49 93 94

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026