Brain-dead Organ DonorsPhase 3ATROPINENCT07166991
Anesthesia sTrategy foR Organ Procurement In braiN dEath
A Phase 3 study testing Volatile anesthetic, Opioid Anesthesia and Intraoperative brain-dead donor management in people with Brain-dead Organ Donors, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain-dead Organ Donors
- What is being tested?
- Volatile anesthetic, Opioid Anesthesia and Intraoperative brain-dead donor management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2026to 1 Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble
Benoit CHAMPIGNEULLE, MD, BChampigneulle@chu-grenoble.fr
About this study
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
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.
Read the detailed description
Brain-dead donors (BDD) remain the primary source of grafts for organ transplantation in France and worldwide. The main objective of BDD management, from the diagnosis of brain death in the intensive care unit (ICU) to organ procurement (OP) in the operating room, is to restore or maintain physiological homeostasis in order to preserve graft viability and improve long-term recipient outcomes. ICU management of potential BDD-particularly through donor management goals-has been shown to increase both the number and the quality of transplanted organs.
In contrast, anesthetic management of BDD during OP is less standardized, although surgical manipulation may jeopardize donor homeostasis. Hemodynamic responses to surgical stimuli (e.g., incision and visceral manipulation), such as tachycardia and marked increases in arterial blood pressure, are well described and result from preserved spinal reflexes. These reflexes, and the vasoactive drugs administered to counteract them, may cause intraoperative hemodynamic instability potentially detrimental to grafts.
Opioids have been proposed to attenuate these responses, but they have proven ineffective in suppressing catecholamine release induced by nociceptive surgical stimulation. Volatile anesthetics (in addition to potential protective effects against ischemia-reperfusion injury) may more effectively blunt these reflex responses. However, their benefits during OP in BDD have not been demonstrated. In the absence of evidence, retrospective studies and surveys in the USA and France report wide heterogeneity in anesthetic strategies used during graft harvesting. Volatile anesthetics and opioids remain the most common agents despite the lack of proven benefit compared with no anesthetic use.
This randomized controlled trial is designed to evaluate whether volatile anesthetics (sevoflurane) improve intraoperative hemodynamic stability during OP in BDD, compared with either no anesthetic use or opioid (sufentanil) administration. The hypothesis is that halogenated agents, by blunting spinally mediated hemodynamic responses to surgical stimuli, will provide greater intraoperative hemodynamic stability than no anesthetic or an opioid-based strategy.
- Conditions
- Brain-dead Organ Donors
- Being tested
- Volatile anesthetic, Opioid Anesthesia, Intraoperative brain-dead donor management
- Keywords
- brain-dead organ donors, anesthesia, hemodynamic stability, sevoflurane, volatile anesthesia, sufentanil, opioid agents, organ procurement, organ harvesting, donor management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volatile anestheticDrug
In the volatile anesthetic group, sevoflurane will be administrated during the organ procurement procedure. Administration will be initiated progressively after moving in the operating room and will be pursued until aortic clamping (targeted end-expiratory concentration suggested between 1 and 2%).
No opioid agent (or intravenous hypnotic agent) will be allowed in this group.
Opioid AnesthesiaDrug
In the opioid anesthetic group, intravenous sufentanil will be administrated during the organ procurement procedure. Continuous administration will be initiated after moving in the operating room (suggested dosage : 0,3 µg/kg/h) with supplemental dose if needed (at the discretion of the anesthesia team) and will be pursued until aortic clamping. No hypnotic drug administration will be allowed in this group.
Intraoperative brain-dead donor managementOther
In all groups (experimental and control groups), neuromuscular blocking agents will be administered during the entire procedure, according to national guidelines. In all groups, hemodynamic management (use of vasoactive agents as vasopressors or anti-hypertensive drugs) will be done according to the discretion of the anesthesia team.
In all groups, all the others aspects of the donor management will be not modified by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Volatile anesthetic group | Experimental | Sevoflurane administration during the organ procurement procedure Receives: Drug: Volatile anesthetic; Other: Intraoperative brain-dead donor management |
| Opioid anesthetic group | Active comparator | Sufentanil administration during the organ procurement procedure Receives: Drug: Opioid Anesthesia; Other: Intraoperative brain-dead donor management |
| No anesthetic drug group | Active comparator | No hypnotic (volatil anesthetics or intravenous anesthetics) or analgesic (opioid agents) drug administration during the organ procurement procedure Receives: Other: Intraoperative brain-dead donor management |
What is being measured
The primary outcome is the main question the study is designed to answer.
A hierarchical endpoint of hemodynamic stability during the organ procurement procedure
Proportion of intraoperative time (between initial skin incision and aortic clamping) with a mean arterial blood pressure between 65 and 75 mmHg, between the volatile anesthetic group of brain-dead donors and :
- The no anesthetic drug group of brain-dead donors.
- The opioid anesthetic group of brain-dead donors.
Measured: Operative time
Secondary outcomes (15)
Comparaison of the hemodynamic stability during the organ procurement procedure between the no anesthetic drug group and the opioid anesthetic group of brain-dead donors
Proportion of intraoperative time (between initial skin incision and aortic clamping) with a mean arterial blood pressure between 65 and 75 mmHg.
Measured: Operative time
Between-group comparaison of the proportion of intraoperative time spent in hypotention
Relative duration of intraoperative time (from initial skin incision to aortic clamping) spent with a mean arterial pressure < 60 mmHg.
Measured: Operative time
Between-group comparaison of the proportion of brain-dead donors with a hemodynamic response at initial surgical incision
Occurrence of an increase in systolic blood pressure ≥ 20%, within 5 minutes of the initial surgical incision, compared with the mean systolic blood pressure registered in the 1 to 5 min preceding the initial surgical incision.
Measured: Operative time
Between-group comparaison of the proportion of brain-dead donors with a hemodynamic response to sternotomy
Occurrence of an increase in systolic blood pressure ≥ 20%, in the 5 minutes following sternotomy, compared with the mean systolic blood pressure measured in the 1 to 5 min preceding sternotomy, in the subgroup of brain-death donors who underwent an intra-thoracic organ harvesting.
Measured: Operative time
Between-group comparaison of the mean arterial blood pressure variability during the organ procurement procedure
Intraoperative variability of the mean arterial pressure measuring using the average real variability (ARV) index of mean arterial pressure.
Measured: Operative time
Between-group comparaison of the mean arterial blood pressure variability during the organ procurement procedure
Intraoperative variability of the mean arterial pressure measuring using the intra-individual standard deviation of mean arterial pressure measurements (SD-MAP).
Measured: Operative time
Between-group comparaison of the mean dose of catecholamines administered during the organ procurement procedure
Intraoperative mean dose (µg/kg/min or U/min) of each catecholamine administered (noradrenaline, adrenaline, dobutamine, vasopressin) and intraoperative mean norepinephrine equivalent score.
Measured: Operative time
Between-group comparaison of the total intraoperative volume of vascular filling
Volume by type of feeling solution during the organ procurement procedure
Measured: Operative time
Between-group comparaison of the total intraoperative volume of labile blood products
Volume of labile blood products by type during the organ procurement procedure
Measured: Operative time
Between-group comparaison of the number of organs harvested and transplanted
Number of solid organs (heart, lungs, liver, kidneys) harvested and effectivelly transplanted by brain-dead donors.
Measured: 24 hours
Between-group comparison of the rate of delayed graft function of the kidney
Delayed graft function of the kidney in the recipient defined as the need for dialysis within 7 days post-transplant.
Measured: 7 days post-transplant
Between-group comparison of the rate of primary lung graft dysfunction
Primary lung graft dysfunction in the recipient, as defined by the French Biomedicine Agency: Existence within 72 hours post-transplant of diffuse pulmonary opacities, the severity of which is graded from 1 to 3, depending on the PaO2/FiO2 ratio (< 200, 200-300, >300) or the need for extracorporeal oxygenation (grade 3).
Measured: 72 hours
Between-group comparison of the rate of primary heart graft dysfunction
Primary heart graft dysfunction in the recipient, as defined by the French Biomedicine Agency: left ventricular ejection fraction < 30% (ultrasound), and/or need for mechanical circulatory assistance, re-transplantation or death of the recipient within 24 hours post-transplant.
Measured: 24 hours
Between-group comparison of the rate of primary liver graft dysfunction
Primary liver graft dysfunction in the recipient, as defined by the French Biomedicine Agency: bilirubin ≥ 10mg/dL on day 7, international normalized ratio ≥ 1.6 on day 7, and alanine or aspartate aminotransferases >2000 IU/L within the first 7 days
Measured: 7 days post-transplant
Describe the number of donor management goals achieved in the 12 hours prior and during the organ procurement procedure
Describe the number of donor management goals achieved in the 12 hours prior and during the organ procurement procedure, including the following:
- Heart rate between 60 and 120 /min,
- Diuresis between 1 and 1.5 mL/kg/h,
- PaO2 / FiO2 ratio > 250 (if lung harvested),
- Hemoglobin > 7 g/dL (10 g/dL if intrathoracic harvesting),
- Blood glucose between 5 and 8 mmol/L,
- Natremia < 155 mmol/L,
- Core temperature > 35°C.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start17 Feb 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Brain-dead Organ DonorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit CHAMPIGNEULLE, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166991
- Sponsor's protocol ID
- 38RC24.0238
- Acronym
- ATROPINE
- Status last verified
- Feb 2026
- First submitted
- 21 May 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fitzgerald RD, Dechtyar I, Templ E, Fridrich P, Lackner FX. Cardiovascular and catecholamine response to surgery in brain-dead organ donors. Anaesthesia. 1995 May;50(5):388-92. doi: 10.1111/j.1365-2044.1995.tb05989.x.
PubMed 7793540Conci F, Procaccio F, Arosio M, Boselli L. Viscero-somatic and viscero-visceral reflexes in brain death. J Neurol Neurosurg Psychiatry. 1986 Jun;49(6):695-8. doi: 10.1136/jnnp.49.6.695.
PubMed 3525756Wetzel RC, Setzer N, Stiff JL, Rogers MC. Hemodynamic responses in brain dead organ donor patients. Anesth Analg. 1985 Feb;64(2):125-8.
PubMed 3882020Fitzgerald RD, Hieber C, Schweitzer E, Luo A, Oczenski W, Lackner FX. Intraoperative catecholamine release in brain-dead organ donors is not suppressed by administration of fentanyl. Eur J Anaesthesiol. 2003 Dec;20(12):952-6. doi: 10.1017/s0265021503001534.
PubMed 14690096Elkins LJ. Inhalational anesthesia for organ procurement: potential indications for administering inhalational anesthesia in the brain-dead organ donor. AANA J. 2010 Aug;78(4):293-9.
PubMed 20879630Souter MJ, Eidbo E, Findlay JY, Lebovitz DJ, Moguilevitch M, Neidlinger NA, Wagener G, Paramesh AS, Niemann CU, Roberts PR, Pretto EA Jr. Organ Donor Management: Part 1. Toward a Consensus to Guide Anesthesia Services During Donation After Brain Death. Semin Cardiothorac Vasc Anesth. 2018 Jun;22(2):211-222. doi: 10.1177/1089253217749053. Epub 2017 Dec 24.
PubMed 29276852Boutin C, Vachiery-Lahaye F, Alonso S, Louart G, Bouju A, Lazarovici S, Perrigault PF, Capdevila X, Jaber S, Colson P, Jonquet O, Ripart J, Lefrant JY, Muller L; pour le groupe AzuRea. [Anaesthetic management of brain-dead for organ donation: impact on delayed graft function after kidney transplantation]. Ann Fr Anesth Reanim. 2012 May;31(5):427-36. doi: 10.1016/j.annfar.2011.11.027. Epub 2012 Apr 26. French.
PubMed 22541983Perez-Protto S, Nazemian R, Matta M, Patel P, Wagner KJ, Latifi SQ, Lebovitz DJ, Reynolds JD. The effect of inhalational anaesthesia during deceased donor organ procurement on post-transplantation graft survival. Anaesth Intensive Care. 2018 Mar;46(2):178-184. doi: 10.1177/0310057X1804600206.
PubMed 29519220Lele AV, Vail EA, O'Reilly-Shah VN, DeGraw X, Domino KB, Walters AM, Fong CT, Gomez C, Naik BI, Mori M, Schonberger R, Deshpande R, Souter MJ; MPOG Perioperative Clinical Research Committee. Identifying Variation in Intraoperative Management of Brain-Dead Organ Donors and Opportunities for Improvement: A Multicenter Perioperative Outcomes Group Analysis. Anesth Analg. 2025 Jan 1;140(1):41-50. doi: 10.1213/ANE.0000000000007001. Epub 2024 Jul 25.
PubMed 39167559Lele AV, Nair BG, Fong C, Walters AM, Souter MJ. Anesthetic Management of Brain-dead Adult and Pediatric Organ Donors: The Harborview Medical Center Experience. J Neurosurg Anesthesiol. 2022 Jan 1;34(1):e34-e39. doi: 10.1097/ANA.0000000000000683.
PubMed 32149890Champigneulle B, Neuschwander A, Bronchard R, Fave G, Josserand J, Lebas B, Bastien O, Pirracchio R; SFAR research network. Intraoperative management of brain-dead organ donors by anesthesiologists during an organ procurement procedure: results from a French survey. BMC Anesthesiol. 2019 Jun 15;19(1):108. doi: 10.1186/s12871-019-0766-y.
PubMed 31202272
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07166991
- Acronym / sponsor ID
- ATROPINE / 38RC24.0238
- Conditions
- Brain-dead Organ Donors
- Keywords
- brain-dead organ donors, anesthesia, hemodynamic stability, sevoflurane, volatile anesthesia, sufentanil, opioid agents, organ procurement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Brain-dead donors (BDD) remain the primary source of grafts for organ transplantation in France and worldwide. The main objective of BDD management, from the diagnosis of brain death in the intensive care unit (ICU) to organ procurement (OP) in the operating room, is to restore or maintain physiological homeostasis in order to preserve graft viability and improve long-term recipient outcomes. ICU management of potential BDD-particularly through donor management goals-has been shown to increase both the number and the quality of transplanted organs.
In contrast, anesthetic management of BDD during OP is less standardized, although surgical manipulation may jeopardize donor homeostasis. Hemodynamic responses to surgical stimuli (e.g., incision and visceral manipulation), such as tachycardia and marked increases in arterial blood pressure, are well described and result from preserved spinal reflexes. These reflexes, and the vasoactive drugs administered to counteract them, may cause intraoperative hemodynamic instability potentially detrimental to grafts.
Opioids have been proposed to attenuate these responses, but they have proven ineffective in suppressing catecholamine release induced by nociceptive surgical stimulation. Volatile anesthetics (in addition to potential protective effects against ischemia-reperfusion injury) may more effectively blunt these reflex responses. However, their benefits during OP in BDD have not been demonstrated. In the absence of evidence, retrospective studies and surveys in the USA and France report wide heterogeneity in anesthetic strategies used during graft harvesting. Volatile anesthetics and opioids remain the most common agents despite the lack of proven benefit compared with no anesthetic use.
This randomized controlled trial is designed to evaluate whether volatile anesthetics (sevoflurane) improve intraoperative hemodynamic stability during OP in BDD, compared with either no anesthetic use or opioid (sufentanil) administration. The hypothesis is that halogenated agents, by blunting spinally mediated hemodynamic responses to surgical stimuli, will provide greater intraoperative hemodynamic stability than no anesthetic or an opioid-based strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Volatile anesthetic group | Experimental | Drug: Volatile anesthetic, Other: Intraoperative brain-dead donor managementSevoflurane administration during the organ procurement procedure |
| Opioid anesthetic group | Active comparator | Drug: Opioid Anesthesia, Other: Intraoperative brain-dead donor managementSufentanil administration during the organ procurement procedure |
| No anesthetic drug group | Active comparator | Other: Intraoperative brain-dead donor managementNo hypnotic (volatil anesthetics or intravenous anesthetics) or analgesic (opioid agents) drug administration during the organ procurement procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligible adult brain-dead donor hospitalized in intensive care unit in one of the participating center:
- 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.
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volatile anestheticIn the volatile anesthetic group, sevoflurane will be administrated during the organ procurement procedure. Administration will be initiated progressively after moving in the operating room and will be pursued until aortic clamping (targeted end-expiratory concentration suggested between 1 and 2%). No opioid agent (or intravenous hypnotic agent) will be allowed in this group. | Drug | Volatile anesthetic group |
| Opioid AnesthesiaIn the opioid anesthetic group, intravenous sufentanil will be administrated during the organ procurement procedure. Continuous administration will be initiated after moving in the operating room (suggested dosage : 0,3 µg/kg/h) with supplemental dose if needed (at the discretion of the anesthesia team) and will be pursued until aortic clamping. No hypnotic drug administration will be allowed in this group. | Drug | Opioid anesthetic group |
| Intraoperative brain-dead donor managementIn all groups (experimental and control groups), neuromuscular blocking agents will be administered during the entire procedure, according to national guidelines. In all groups, hemodynamic management (use of vasoactive agents as vasopressors or anti-hypertensive drugs) will be done according to the discretion of the anesthesia team. In all groups, all the others aspects of the donor management will be not modified by the study protocol. | Other | No anesthetic drug group, Opioid anesthetic group, Volatile anesthetic group |
Primary outcome
A hierarchical endpoint of hemodynamic stability during the organ procurement procedure
Time frame: Operative time
Proportion of intraoperative time (between initial skin incision and aortic clamping) with a mean arterial blood pressure between 65 and 75 mmHg, between the volatile anesthetic group of brain-dead donors and : 1. The no anesthetic drug group of brain-dead donors. 2. The opioid anesthetic group of brain-dead donors.
15 secondary outcomes
Comparaison of the hemodynamic stability during the organ procurement procedure between the no anesthetic drug group and the opioid anesthetic group of brain-dead donors
Time frame: Operative time
Between-group comparaison of the proportion of intraoperative time spent in hypotention
Time frame: Operative time
Between-group comparaison of the proportion of brain-dead donors with a hemodynamic response at initial surgical incision
Time frame: Operative time
Between-group comparaison of the proportion of brain-dead donors with a hemodynamic response to sternotomy
Time frame: Operative time
Between-group comparaison of the mean arterial blood pressure variability during the organ procurement procedure
Time frame: Operative time
Between-group comparaison of the mean arterial blood pressure variability during the organ procurement procedure
Time frame: Operative time
Between-group comparaison of the mean dose of catecholamines administered during the organ procurement procedure
Time frame: Operative time
Between-group comparaison of the total intraoperative volume of vascular filling
Time frame: Operative time
Between-group comparaison of the total intraoperative volume of labile blood products
Time frame: Operative time
Between-group comparaison of the number of organs harvested and transplanted
Time frame: 24 hours
Between-group comparison of the rate of delayed graft function of the kidney
Time frame: 7 days post-transplant
Between-group comparison of the rate of primary lung graft dysfunction
Time frame: 72 hours
Between-group comparison of the rate of primary heart graft dysfunction
Time frame: 24 hours
Between-group comparison of the rate of primary liver graft dysfunction
Time frame: 7 days post-transplant
Describe the number of donor management goals achieved in the 12 hours prior and during the organ procurement procedure
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 7793540Fitzgerald RD, Dechtyar I, Templ E, Fridrich P, Lackner FX. Cardiovascular and catecholamine response to surgery in brain-dead organ donors. Anaesthesia. 1995 May;50(5):388-92. doi: 10.1111/j.1365-2044.1995.tb05989.x.
- Background: PubMed 3525756Conci F, Procaccio F, Arosio M, Boselli L. Viscero-somatic and viscero-visceral reflexes in brain death. J Neurol Neurosurg Psychiatry. 1986 Jun;49(6):695-8. doi: 10.1136/jnnp.49.6.695.
- Background: PubMed 3882020Wetzel RC, Setzer N, Stiff JL, Rogers MC. Hemodynamic responses in brain dead organ donor patients. Anesth Analg. 1985 Feb;64(2):125-8.
- Background: PubMed 14690096Fitzgerald RD, Hieber C, Schweitzer E, Luo A, Oczenski W, Lackner FX. Intraoperative catecholamine release in brain-dead organ donors is not suppressed by administration of fentanyl. Eur J Anaesthesiol. 2003 Dec;20(12):952-6. doi: 10.1017/s0265021503001534.
- Background: PubMed 20879630Elkins LJ. Inhalational anesthesia for organ procurement: potential indications for administering inhalational anesthesia in the brain-dead organ donor. AANA J. 2010 Aug;78(4):293-9.
- Background: PubMed 29276852Souter MJ, Eidbo E, Findlay JY, Lebovitz DJ, Moguilevitch M, Neidlinger NA, Wagener G, Paramesh AS, Niemann CU, Roberts PR, Pretto EA Jr. Organ Donor Management: Part 1. Toward a Consensus to Guide Anesthesia Services During Donation After Brain Death. Semin Cardiothorac Vasc Anesth. 2018 Jun;22(2):211-222. doi: 10.1177/1089253217749053. Epub 2017 Dec 24.
- Background: PubMed 22541983Boutin C, Vachiery-Lahaye F, Alonso S, Louart G, Bouju A, Lazarovici S, Perrigault PF, Capdevila X, Jaber S, Colson P, Jonquet O, Ripart J, Lefrant JY, Muller L; pour le groupe AzuRea. [Anaesthetic management of brain-dead for organ donation: impact on delayed graft function after kidney transplantation]. Ann Fr Anesth Reanim. 2012 May;31(5):427-36. doi: 10.1016/j.annfar.2011.11.027. Epub 2012 Apr 26. French.
- Background: PubMed 29519220Perez-Protto S, Nazemian R, Matta M, Patel P, Wagner KJ, Latifi SQ, Lebovitz DJ, Reynolds JD. The effect of inhalational anaesthesia during deceased donor organ procurement on post-transplantation graft survival. Anaesth Intensive Care. 2018 Mar;46(2):178-184. doi: 10.1177/0310057X1804600206.
- Background: PubMed 39167559Lele AV, Vail EA, O'Reilly-Shah VN, DeGraw X, Domino KB, Walters AM, Fong CT, Gomez C, Naik BI, Mori M, Schonberger R, Deshpande R, Souter MJ; MPOG Perioperative Clinical Research Committee. Identifying Variation in Intraoperative Management of Brain-Dead Organ Donors and Opportunities for Improvement: A Multicenter Perioperative Outcomes Group Analysis. Anesth Analg. 2025 Jan 1;140(1):41-50. doi: 10.1213/ANE.0000000000007001. Epub 2024 Jul 25.
- Background: PubMed 32149890Lele AV, Nair BG, Fong C, Walters AM, Souter MJ. Anesthetic Management of Brain-dead Adult and Pediatric Organ Donors: The Harborview Medical Center Experience. J Neurosurg Anesthesiol. 2022 Jan 1;34(1):e34-e39. doi: 10.1097/ANA.0000000000000683.
- Background: PubMed 31202272Champigneulle B, Neuschwander A, Bronchard R, Fave G, Josserand J, Lebas B, Bastien O, Pirracchio R; SFAR research network. Intraoperative management of brain-dead organ donors by anesthesiologists during an organ procurement procedure: results from a French survey. BMC Anesthesiol. 2019 Jun 15;19(1):108. doi: 10.1186/s12871-019-0766-y.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 2
Potassium Canrenoate in Brain-dead Organ Donors: Randomized Controlled Clinical Trial
Brain-dead Organ Donors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benoit CHAMPIGNEULLE, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Volatile anesthetic, Opioid Anesthesia and Intraoperative brain-dead donor management in people with Brain-dead Organ Donors, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoit CHAMPIGNEULLE, MD, PhD (+33476766879, BChampigneulle@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A hierarchical endpoint of hemodynamic stability during the organ procurement procedure (time frame: Operative time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07166991, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.