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Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure

Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure. Prospective Observational Multicenter Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06780722
Acronym
HEPHAISTOS
Enrollment
50
Registered
2025-01-17
Start date
2025-12-19
Completion date
2027-06-19
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Reanimation

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.

Interventions

OTHERblood 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.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
PaO2 level24 hoursPaO2 level and its 95% confidence interval in the event of circulatory cardiac arrest, defined as a pulse pressure below 5 mmHg, during a Maastricht III procedure.

Secondary

MeasureTime frameDescription
Spo2 Level24 hoursDefine the level of Spo2 (and its 95% confidence interval) at the time of cardiocirculatory arrest during a Maastricht III procedure.
Time between occurrence of first episode of pulsed oxygen saturation below 95% and onset of cardiocirculatory arrest24 hoursDefine the time (and its 95% confidence interval) between the occurrence of the first first episode of pulsed oxygen saturation below 95% and the onset of cardio-circulatory arrest defined by absence of pulsed pressure below 5 mmHg.
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.7 daysDelayed recovery of renal function will be confirmed if the recipient undergoes dialysis within the first 7 days after transplantation. Hypoxemia is defined as a PaO2 less than or equal to the median value.

Countries

France

Contacts

CONTACTJean Baptiste LASCARROU
Jeanbaptiste.lascarrou@chu-nantes.fr02 40 08 73 76

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026