NCT07166991 Anesthesia sTrategy foR Organ Procurement In braiN dEath
| NCT ID | NCT07166991 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Grenoble |
| Condition | Brain-dead Organ Donors |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2026-02-17 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 270 participants in total. It began in 2026-02-17 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The optimal anesthetic strategy during organ procurement in brain-dead donors remains unknown. The administration of anesthetic drugs in this setting aims to preserve hemodynamic stability in the face of reflex responses mediated by preserved spinal activity. Volatile anesthetics may blunt these reflexes, but their potential benefits in this context have never been investigated. This randomized trial evaluates the effects of volatile anesthesia (sevoflurane), opioid administration (sufentanil), or no anesthetic drugs on intraoperative hemodynamic stability during organ procurement in brain-dead donors. The primary outcome is the proportion of operative time within a predefined arterial blood pressure range.
Eligibility Criteria
Inclusion Criteria: * Eligible adult brain-dead donor hospitalized in intensive care unit in one of the participating center: * Confirmed diagnosis of brain death according to French public health code. * Ongoing organ donation procedure managed by the local organ procurement coordination team with confirmation of the potential procurement of at least one intra-abdominal or intra-thoracic organ. * Transfer to the operating room for the organ procurement procedure scheduled for the next 6 hours and anesthesia team alerted. * Information of the patient's next of kin by the investigator and absence of opposition to research confirmed by the testimony of the next of kin according to French public health code. Exclusion Criteria: * Age \< 18 years. * DCD (donation after circulatory death) donors. * Ongoing extracorporeal circulation at the time of death. * Hemodynamic instability at the screening visit defined by a noradrenalin dose \> 1 µg/kg/min. * Contraindication to the implementation of the anesthetic interventions evaluated in the trial: * Prior history of opioid or volatil anesthetic agents allergy. * Prior personal or family history of malignant hyperthermia or history of myopathy at risk of malignant hyperthermia. * Opposition to the research expressed by the patient during his or her lifetime and documented by the next of kin.
Contact & Investigator
Benoit CHAMPIGNEULLE, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Grenoble
Frequently Asked Questions
Who can join the NCT07166991 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain-dead Organ Donors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07166991 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 270 participants.
Is NCT07166991 currently recruiting?
Yes, NCT07166991 is actively recruiting participants. Contact the research team at BChampigneulle@chu-grenoble.fr for enrollment information.
Where is the NCT07166991 trial being conducted?
This trial is being conducted at Grenoble, France.
Who is sponsoring the NCT07166991 clinical trial?
NCT07166991 is sponsored by University Hospital, Grenoble. The principal investigator is Benoit CHAMPIGNEULLE, MD, PhD at University Hospital, Grenoble. The trial plans to enroll 270 participants.