Anesthesia strategies for organ removal from brain-dead donors
Official title: Impact of a Specific Anesthetic Strategy on Intraoperative Hemodynamic Stability During Organ Procurement in Brain Dead Donor: An Open-label Multicenter Randomized and Controlled Trial
Run by University Hospital, Grenoble · NCT07166991 · Data updated 2026-11-12
This trial tests whether using a volatile anesthetic (sevoflurane), giving an opioid (sufentanil), or giving no anesthetic during organ removal from brain-dead donors helps keep blood pressure more stable.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 270 (estimated) |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble) |
| Status | Recruiting |
| Started | February 17, 2026 |
| Main results expected | September 1, 2028 |
| Study ends | September 1, 2029 |
| Registry record updated | February 23, 2026 |
| Trial ID | NCT07166991 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult brain-dead donors confirmed under French law, with no opposition from next of kin, scheduled for intra-abdominal or intra-thoracic organ procurement at a participating center and hemodynamically stable enough for transfer to the OR (noradrenaline ≤1 µg/kg/min) are eligible.
✕Probably not a fit
Donors after circulatory death, donors under 18, those on extracorporeal circulation, those requiring very high vasopressor support (>1 µg/kg/min), or with contraindications to volatile anesthetics or opioids are ineligible and unlikely to benefit from the interventions tested.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized phase 3 trial comparing three intraoperative strategies—volatile anesthesia with sevoflurane, opioid anesthesia with sufentanil, or no anesthetic drugs—in adult brain-dead donors undergoing organ procurement. The primary outcome is the proportion of operative time during which arterial blood pressure stays within a predefined target range. Donors are enrolled after confirmed brain death, with next-of-kin information and no opposition, and must be transferred to the operating room within about six hours. The trial is conducted at CHU Grenoble Alpes and measures intraoperative hemodynamic stability to inform donor management practices.
Why it matters
Potential benefit: If successful, the approach could improve donor blood-pressure stability during organ removal and thereby help preserve organ quality and improve transplant outcomes.
How similar studies have gone: Volatile anesthetics have physiological and preclinical rationale and some surrogate evidence for organ protection, but randomized data on their benefit during organ procurement in brain-dead donors are lacking.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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CHU Grenoble Alpes
Grenoble, France Recruiting
Study contacts
- Principal investigator: Benoit CHAMPIGNEULLE, MD, PhD — University Hospital, Grenoble
- Study coordinator: Benoit CHAMPIGNEULLE, MD, PhD
- Email: BChampigneulle@chu-grenoble.fr
- Phone: +33476766879
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.