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

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.

Study Overview

• Status: Recruiting
• Conditions: Death, Brain
• Intervention / Treatment: Other: No interventtion

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Maxime COUTROT, MD; Phone Number: +33 1 42 49 93 94; Email: maxime.coutrot@aphp.fr
• Study Contact Backup: Name: François DEPRET, MD; Phone Number: +33 1 42 49 93 94; Email: francois.depret@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • Not yet recruiting
    • Hôpital Saint-Louis, AP-HP
    • Contact: Maxime COUTROT, MD
  • Paris, France, 75013
    • Recruiting
    • Hôpital Pitié Salpêtrière AP-HP
    • Contact: Frank Ferrari, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; to enhance the understanding of the factors associated with the number of organs retrieved from patients admitted to the ICU for organ donation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Société Française d'Anesthésie et de Réanimation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Estimated): February 15, 2026
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neurobehavioral Manifestations; Death; Consciousness Disorders; Unconsciousness; Coma; Brain Death
• Other Study ID Numbers: 2024-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No