Clinical trial NCT06780722: Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure
Official title: Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure. Prospective Observational Multicenter Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Arrest
Reanimation
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who may be candidates for an organ donation procedure in the event of death in intensive care following the implementation of a procedure to discontinue active therapies.

Brief summary: Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.

Detailed description: Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.

Eligibility criteria: FOR THE DONORS :

Inclusion Criteria :

* Patient over 18 years of age
* Organ donation procedure initiated in accordance with the legislation and procedures in force in France for the Maastricht III category
* No opposition formulated by the relative to the patient's participation in the study

Exclusion Criteria :

* Patient registered on the national register of refusals or living refusal of donation
* Pregnant or breast-feeding women
* Patients under guardianship, curatorship or legal protection
* Medical contraindication to organ donation according to the recommendations of the Agence de Biomédecine currently in force in France

FOR THE RECEIVER

Inclusion Criteria :

* No opposition to the collection of data concerning him/her
* Patient over 18 at pre-transplant consultation
* Patient who has received an organ from a donor participating in the HEPHAISTOS protocol

Exclusion Criteria :

- Patients under guardianship, curatorship or legal protection

Primary outcomes:
measure: PaO2 level
timeFrame: 24 hours
Secondary outcomes:
measure: Spo2 Level
timeFrame: 24 hours
measure: Time between occurrence of first episode of pulsed oxygen saturation below 95% and onset of cardiocirculatory arrest
timeFrame: 24 hours
measure: Correlation between the rate of delayed recovery of renal function in the recipient and the presence of hypoxemia at the time of cardiocirculatory arrest in the donor.
timeFrame: 7 days
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU ANGERS - Réanimation médicale
city: Angers
country: France
facility: CHU ANGERS - Urgences - Coordination Prélèvements
city: Annecy
country: France
facility: CH ANNECY GENEVOIS - Réanimation médicale - Coordination Prélèvements multi-organes
city: Avignon
country: France
facility: CH AVIGNON - CH Henri Duffaut - Réanimation polyvalente
city: La Roche-sur-Yon
country: France
facility: CHD Vendée - Les Oudairies - Médecine Intensive Réanimation -Coordination Prélèvements multi-organes
city: La Roche-sur-Yon
country: France
facility: CHD Vendée - Les Oudairies - Médecine Intensive Réanimation
city: Lille
country: France
facility: CHU LILLE - Hôpital Roger Salengro - Coordination prélèvements multi-organes
city: Lille
country: France
facility: CHU LILLE - Hôpital Roger Salengro - Médecine Intensive Réanimation
city: Nantes
country: France
facility: CHU NANTES +- Médecine Intensive Réanimation
city: Nantes
country: France
facility: CHU Nantes - Coordination prélèvement multi organes
city: Orléans
country: France
facility: CHRU ORLEANS -Médecine Intensive Réanimation - Coordination Prélèvements multi-organes
city: Paris
country: France
facility: APHP Hôpital COCHIN - Coordination Prélèvements d'Organes et Tissus
city: Paris
country: France
facility: APHP Hôpital COCHIN - Médecine Intensive Réanimation
city: Poitiers
country: France
facility: CHU POITIERS - Anesthésie Réanimation - Coordination Prélèvements multi-organes
city: Périgueux
country: France
facility: CH PERIGUEUX - Réanimation - Coordination Prélèvements Organes et Tissus
city: Rennes
country: France
facility: CHU RENNES - CHU Pontchaillou - Réanimation médicale
city: Tours
country: France
facility: CHRU TOURS - Hôpital Bretonneau - Coordination Prélèvements multi-organes
city: Tours
country: France
facility: CHRU TOURS - Hôpital Bretonneau - Médecine Intensive Réanimation
city: Vannes
country: France
facility: CHBA Vannes-Auray - Réanimation Polyvalente
Study officials:
References: