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

NCT06768515 | Recruiting

• 1 other identifier: 2024-04
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Death, Brain

Outcome Measures

Primary Outcomes (9)

• Mean arterial pressure

  Mean arterial pressure (MAP) between 60 and 110 mmHg

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

• Central venous pressure

  Central venous pressure (CVP) between 4 and 12 mmHg

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

• Left ventricular ejection fraction

  Left ventricular ejection fraction (LVEF) ≥ 50%

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

• vasopressor

  Low doses and a single vasopressor. (≤10 µg/kg/min of dopamine or ≤60 µg/min of Neosynephrine or ≤10 µg/min of norepinephrine))

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

• Arterial pH

  Arterial pH between 7.3 and 7.5

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

• PaO2/FiO2

  PaO2/FiO2 ≥ 300

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

• Sodium levels

  Sodium levels ≤ 155 mmol/L

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

• Diuresis

  Diuresis ≥ 0.5 mL/kg/h

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

• Blood glucose

  Blood glucose ≤ 1.5 g/L

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

Secondary Outcomes (12)

• 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

Study Arms (1)

Organ donation

Patients over 18 years of age, hospitalized in the ICU In a state of brain death No objection to organ donation during their lifetime

Other: No interventtion

Interventions

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

Organ donation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in a state of brain dead. Patients meeting the inclusion criteria from January 1, 2022, to December 31, 2024, will be included in the study.

You may qualify if:

• 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

You may not qualify if:

• Objection to the use of their data during their lifetime
• Registration in the national refusal registry

Sponsors & Collaborators

• Société Française d'Anesthésie et de Réanimation: lead

Study Sites (2)

Hôpital Saint-Louis, AP-HP

Paris, 75010, France

NOT YET RECRUITING

Hôpital Pitié Salpêtrière AP-HP

Paris, 75013, France

RECRUITING

Related Publications (6)

• Malinoski DJ, Patel MS, Daly MC, Oley-Graybill C, Salim A; UNOS Region 5 DMG workgroup. The impact of meeting donor management goals on the number of organs transplanted per donor: results from the United Network for Organ Sharing Region 5 prospective donor management goals study. Crit Care Med. 2012 Oct;40(10):2773-80. doi: 10.1097/CCM.0b013e31825b252a.

  PMID: 22846779 BACKGROUND

• Oniscu GC, Rockell K, Martin DE. Challenges in undertaking research in transplantation. Lancet. 2025 Mar 1;405(10480):681-683. doi: 10.1016/S0140-6736(24)00931-0. Epub 2024 May 21. No abstract available.

  PMID: 38788740 BACKGROUND

• iomedecine, P. Chiffres 2022 de l'activité de prélèvement et de greffe d'organes et de tissus et Baromète 2023 sur la connaissance et la perception du don d'organes en France.

  BACKGROUND

• Patel MS, De La Cruz S, Sally MB, Groat T, Malinoski DJ. Active Donor Management During the Hospital Phase of Care Is Associated with More Organs Transplanted per Donor. J Am Coll Surg. 2017 Oct;225(4):525-531. doi: 10.1016/j.jamcollsurg.2017.06.014. Epub 2017 Jul 21.

  PMID: 28739153 RESULT

• Bera KD, Shah A, English MR, Harvey D, Ploeg RJ. Optimisation of the organ donor and effects on transplanted organs: a narrative review on current practice and future directions. Anaesthesia. 2020 Sep;75(9):1191-1204. doi: 10.1111/anae.15037. Epub 2020 May 19.

  PMID: 32430910 RESULT

• Patel MS, Zatarain J, De La Cruz S, Sally MB, Ewing T, Crutchfield M, Enestvedt CK, Malinoski DJ. The impact of meeting donor management goals on the number of organs transplanted per expanded criteria donor: a prospective study from the UNOS Region 5 Donor Management Goals Workgroup. JAMA Surg. 2014 Sep;149(9):969-75. doi: 10.1001/jamasurg.2014.967.

  PMID: 25054379 RESULT

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maxime COUTROT, MD

CONTACT

+33 1 42 49 93 94; maxime.coutrot@aphp.fr

François DEPRET, MD

CONTACT

+33 1 42 49 93 94; francois.depret@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 10, 2025
• Study Start: April 23, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 15, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

FR (2)