Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood sampling.
- Who it may be relevant to
- Registry conditions: Cardiac Arrest, Reanimation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other blood sampling
* The first sample is taken at the start of the therapeutic stop. * The second sample is taken when the mean arterial pressure drops to 45mmHg. * The third sample is taken when circulatory arrest occurs. * The fourth sample is taken at the start of extracorporeal circulation. These four samples will be destroyed at the end of the study.
Primary outcome measures
- PaO2 level [Time frame: 24 hours]
Secondary outcome measures (3)
- Spo2 Level [Time frame: 24 hours]
- Time between occurrence of first episode of pulsed oxygen saturation below 95% and onset of cardiocirculatory arrest [Time frame: 24 hours]
- 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. [Time frame: 7 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 12 centers
- CHU ANGERS - Réanimation médicale — Angers
- CH ANNECY GENEVOIS - Réanimation médicale - Coordination Prélèvements multi-organes — Annecy
- CH AVIGNON - CH Henri Duffaut - Réanimation polyvalente — Avignon
- CHD Vendée - Les Oudairies - Médecine Intensive Réanimation — La Roche-sur-Yon
- CHU LILLE - Hôpital Roger Salengro - Médecine Intensive Réanimation — Lille
- CHU de Nantes - Hôpital Laennec — Nantes
- CHU NANTES +- Médecine Intensive Réanimation — Nantes
- CHRU ORLEANS -Médecine Intensive Réanimation - Coordination Prélèvements multi-organes — Orléans
- … and 4 more centers
Identifiers
NCT: NCT06780722 · RC22_0498