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

March 25, 2026 updated by: Nantes University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France
        • Recruiting
        • CHU ANGERS - Réanimation médicale
        • Contact:
      • Annecy, France
        • Recruiting
        • CH ANNECY GENEVOIS - Réanimation médicale - Coordination Prélèvements multi-organes
        • Contact:
      • Avignon, France
        • Recruiting
        • CH AVIGNON - CH Henri Duffaut - Réanimation polyvalente
        • Contact:
      • La Roche-sur-Yon, France
        • Recruiting
        • CHD Vendée - Les Oudairies - Médecine Intensive Réanimation
        • Contact:
      • Lille, France
        • Recruiting
        • CHU LILLE - Hôpital Roger Salengro - Médecine Intensive Réanimation
        • Contact:
      • Nantes, France
      • Nantes, France
      • Orléans, France
        • Recruiting
        • CHRU ORLEANS -Médecine Intensive Réanimation - Coordination Prélèvements multi-organes
        • Contact:
      • Poitiers, France
        • Recruiting
        • CHU POITIERS - Anesthésie Réanimation - Coordination Prélèvements multi-organes
        • Contact:
      • Rennes, France
        • Recruiting
        • CHU RENNES - CHU Pontchaillou - Réanimation médicale
        • Contact:
      • Tours, France
        • Recruiting
        • CHRU TOURS - Hôpital Bretonneau - Médecine Intensive Réanimation
        • Contact:
      • Vannes, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PaO2 level
Time Frame: 24 hours
PaO2 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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spo2 Level
Time Frame: 24 hours
Define the level of Spo2 (and its 95% confidence interval) at the time of cardiocirculatory arrest during a Maastricht III procedure.
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
Delayed 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.
7 days
Time between occurrence of first episode of pulsed oxygen saturation below 95% and onset of cardiocirculatory arrest
Time Frame: 24 hours
Define 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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2025

Primary Completion (Estimated)

June 6, 2027

Study Completion (Estimated)

June 19, 2027

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC22_0498

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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