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NCT Number: NCT06768515

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pitié Salpêtrière AP-HP, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No interventtion

Other

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

Primary outcomes

  1. Mean arterial pressure

    Time frame: Between admission to intensive care and brain death and before multi-organ retrieval

    Mean arterial pressure (MAP) between 60 and 110 mmHg

  2. Central venous pressure

    Time frame: Within 7 last days before brain death and before multi-organ retrieval

    Central venous pressure (CVP) between 4 and 12 mmHg

  3. Left ventricular ejection fraction

    Time frame: Between admission to intensive care and brain death and before multi-organ retrieval

    Left ventricular ejection fraction (LVEF) ≥ 50%

  4. vasopressor

    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))

  5. Arterial pH

    Time frame: Between admission to intensive care and brain death and before multi-organ retrieval

    Arterial pH between 7.3 and 7.5

  6. PaO2/FiO2

    Time frame: Between admission to intensive care and brain death and before multi-organ retrieval

    PaO2/FiO2 ≥ 300

  7. Sodium levels

    Time frame: Between admission to intensive care and brain death and before multi-organ retrieval

    Sodium levels ≤ 155 mmol/L

  8. Diuresis

    Time frame: Between admission to intensive care and brain death and before multi-organ retrieval

    Diuresis ≥ 0.5 mL/kg/h

  9. Blood glucose

    Time frame: Between admission to intensive care and brain death and before multi-organ retrieval

    Blood glucose ≤ 1.5 g/L

Secondary outcomes

  1. demographics of Brain dead

    Time frame: Between admission to intensive care and brain death and before multi-organ retrieval

    The demographics of Brain dead

  2. Causes of neurological injury leading to brain death

    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

  3. 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

    Descibe the timelines and durations of patient management before and after brain death

  4. 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 organ failures before and after brain death

  5. 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 acute kidney failure before and after brain death

  6. 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 infections, sepsis, and septic shock before and after brain death

  7. Incidence of diabetes insipidus

    Time frame: Between admission to intensive care and brain death and before multi-organ retrieval

    Describe the incidence of diabetes insipidus

  8. Treatments administered before and after brain death

    Time frame: Between admission to intensive care and brain death and before multi-organ retrieval

    Describe the treatments administered before and after brain death

  9. Number and nature of organs retrieved

    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

  10. Number and nature of organs available for transplantation

    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

  11. 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

    Describe the number of organs placed on ex situ preservation and the type of preservation method used

  12. Number, causes, and associated factors of unsuccessful organ retrieval procedures

    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

Study contacts

Contact information is provided by the study sponsor or research team.

François DEPRET, MD

CONTACT

[email protected]

+33 1 42 49 93 94

Maxime COUTROT, MD

CONTACT

[email protected]

+33 1 42 49 93 94

Sponsors and collaborators

Lead sponsor

Société Française d'Anesthésie et de Réanimation

Other

Registry information

Acronym: DONOR-OBS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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