HypotensionPhase 2/3IMPACTNCT06083948
Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia
A Phase 2/3 study testing Noradrenalin and Phenylephrine in people with Hypotension, run by University of Aarhus at 1 site in Denmark.
Trial summary
The optimal vasopressor for ensuring organ blood flow and tissue oxygen delivery during surgery remains undetermined. This study aim to compare the effects of noradrenaline vs. phenylephrine infusion on blood flow and oxygen delivery to the brain and various other organs in anesthetized neurosurgical patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypotension
- What is being tested?
- Noradrenalin and Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Dec 2023to 31 Dec 2027
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of supratentorial malignant or non-malignant brain tumors. Preferably 3 cm or larger( measured as the largest diameter in any plane on MRI).
- Scheduled for elective supratentorial craniotomy.
- Patients aged between 18 and 75 years.
- American Society of Anesthesiologists status 1-3
Who cannot join
- History of allergy or intolerance to one of the study medications.
- Active treatment with monoamine oxidase inhibitors.
- An American Society of Anesthesiologists (ASA)physical status IV-VI.
- Pregnancy or breastfeeding.
- Inability to provide written informed consent -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Mads Rasmussen, MD, PhD, +4529265713, mads.rasmussen@vest.rm.dk
About this study
Official title: Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia in Neurosurgical Patients
The optimal vasopressor for ensuring organ blood flow and tissue oxygen delivery during surgery remains undetermined. This study aim to compare the effects of noradrenaline vs. phenylephrine infusion on blood flow and oxygen delivery to the brain and various other organs in anesthetized neurosurgical patients.
Read the detailed description
The brain and other blood flow sensitive organs are vulnerable to hypotension during neurosurgery. As a countermeasure, vasopressor agents are often administered to increase blood pressure. The ultimate goal of the vasopressor is to secure perfusion of vital organs and fulfill their metabolic demand. However, the optimal vasopressor for ensuring organ blood flow and tissue oxygen delivery during surgery remains undetermined.The aim of this study is to compare the effects of noradrenaline vs. phenylephrine infusion on blood flow and oxygen consumption in the brain and various other organs in anesthetized neurosurgical patients.
The project constitutes a clinical randomized study involving 32* patients diagnosed with brain tumors. The study is conducted on the same day as their scheduled brain tumor surgery. The study is designed as a randomized, double-blinded clinical trial, with two distinct groups: Group 1 receives phenylephrine, while Group 2 receives noradrenaline.
PET exams of blood flow and oxygen consumption in brain and organs(including myocardium, kidney, liver, spinal cord, organs supplied by the splanchnic circulation, muscle tissue and other organs) are performed using a PET scanner with a wide field of view. The wide field of view allow for simultaneous multiorgan blood flow and oxygen consumption measurements.
Four positron emission tomography (PET) examinations are performed prior to the surgical procedure. The first PET examination (PET 1) is performed on the awake patient. The patient is then anesthetized, and the PET exam is repeated (PET 2). Vasopressor infusion is initiated and titrated to increase mean arterial blood pressure(MABP) above 60 mmHg, or by 10% relative to baseline(baseline MABP is measured prior to PET 2). The PET exam is repeated (PET 3). MABP is further increased to above 70 mmHg or by 20 % relative to the baseline level and the PET exam is repeated (PET 4). The anesthetized patient is then transported to the surgical theatre and surgery is initiated. During the surgical procedure, MABP is maintained between 70-80 mmHg according to institutional guidelines. The vasopressor infusion is terminated after completion of the surgery.. Invasive blood pressure, cardiac output (CO),depth of anesthesia (bispectral index) and brain tissue oxygen saturation(near infrared spectroscopy) are continuously measured.An MRI examination is performed 24 hours after surgery to detect any ischemic lesions possibly associated with the vasopressor infusion.
- The initial sample size of 40 patients was reduced to 32 patients in april 2024 (after inclusion of 4 patients). The change in sample size is due to unexpected limited scanner availability and unexpected difficuties with patient recruitment. These factors will be associated with a longer period of patient inclusion and consequently longer time before study completion which we find unacceptable.
** In a substudy including approximately half of the patients, we plan to describe the physiology of the circulatory system during the transition from wakefulness to general anesthesia. Specifically, we will present the absolute and relative changes in blood flow to the brain and selected non-cerebral organs. The analysis will also assess the redistribution of cardiac output during this transition.
This substudy is intended solely to describe physiological changes occurring during the transition from wakefulness to anesthesia. Only data obtained prior to the randomized part of the protocol will be used, and the substudy is independent of the randomized analyses.
- Conditions
- Hypotension
- Being tested
- Noradrenalin, Phenylephrine
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoradrenalinDrug
Also called Noradrenaline
Infusion of noradrenaline during anesthesia and surgery
PhenylephrineDrug
Also called metaoxedrin
Infusion of phenylephrine during anesthesia and surgery
| Study group | Role | What they receive |
|---|---|---|
| Noradrenaline | Experimental | Noradrenaline Receives: Drug: Noradrenalin |
| Phenylephrine | Active comparator | Phenylephrine Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
Blood flow measured in milliliters per minute through selected regions of the brain as determined by Positron Emission Tomography
Measured: Up to 3 hours (measured on the day of surgery prior to the surgical procedure)
Secondary outcomes (7)
Cerebral metabolic rate of oxygen
Cerebral oxygen consumption in selected regions of the brain as determined by Positron Emission Tomography
Measured: Up to 4 hours (measured on the day of surgery prior to the surgical procedure)
Blood flow through body organs in milliliters per minute as determined by Positron Emission Tomography
Blood flow in various body organs supplied by the systemic circulation
Measured: Up to 4 hours (measured on the day of surgery prior to the surgical procedure)
Blood pumped out by the heart per minute (cardiac output)
Cardiac output as determined by Positron Emission Tomography and/or by beat-to-beat determination by analysis of the arterial blood pressure waveform
Measured: Up to one day
Ischemic lesions
Ischemic lesions possibly associated with vasopressor use as detected on the postoperative MRI examination
Measured: Up to 3 days
Cerebral tissue oxygen saturation
Cerebral tissue oxygen saturation as measured with near infrared spectroscopy (NIRS)
Measured: Up to one day
Bispectral Index (BIS)
Depth of anesthesia as measured by BIS
Measured: Up to one day
Organ metabolic rate of Oxygen
Oxygen consumption in various organs as measured by Positron Emission Tomography
Measured: Up to 3 hours (measured on the day of surgery prior to the surgical procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start20 Dec 2023
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blinded, clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mads Rasmussen, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083948
- Sponsor's protocol ID
- IMPACT study
- Acronym
- IMPACT
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: THe trial data may be shared upon request to the Investigator
Publications
Faisal Mohamad N, Koch KU, Aanerud J, Meier K, Mikkelsen IK, Espelund US, Eriksen CF, Juul N, Alstrup KB, Jespersen B, Fries LM, Tankisi A, Dyrskog S, Cortnum SOS, Sindby AK, Borghammer P, Tolbod LP, Meng L, Korshoej AR, Rasmussen M. Impact of norepinephrine versus phenylephrine on brain circulation, organ blood flow and tissue oxygenation in anaesthetised patients with brain tumours: study protocol for a randomised controlled trial. BMJ Open. 2025 Mar 25;15(3):e095172. doi: 10.1136/bmjopen-2024-095172.
PubMed 40132839
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia in Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT06083948
- Acronym / sponsor ID
- IMPACT / IMPACT study
- Conditions
- Hypotension
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Oct 2023 (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 vasopressor for ensuring organ blood flow and tissue oxygen delivery during surgery remains undetermined. This study aim to compare the effects of noradrenaline vs. phenylephrine infusion on blood flow and oxygen delivery to the brain and various other organs in anesthetized neurosurgical patients.
Detailed description
The brain and other blood flow sensitive organs are vulnerable to hypotension during neurosurgery. As a countermeasure, vasopressor agents are often administered to increase blood pressure. The ultimate goal of the vasopressor is to secure perfusion of vital organs and fulfill their metabolic demand. However, the optimal vasopressor for ensuring organ blood flow and tissue oxygen delivery during surgery remains undetermined.The aim of this study is to compare the effects of noradrenaline vs. phenylephrine infusion on blood flow and oxygen consumption in the brain and various other organs in anesthetized neurosurgical patients.
The project constitutes a clinical randomized study involving 32* patients diagnosed with brain tumors. The study is conducted on the same day as their scheduled brain tumor surgery. The study is designed as a randomized, double-blinded clinical trial, with two distinct groups: Group 1 receives phenylephrine, while Group 2 receives noradrenaline.
PET exams of blood flow and oxygen consumption in brain and organs(including myocardium, kidney, liver, spinal cord, organs supplied by the splanchnic circulation, muscle tissue and other organs) are performed using a PET scanner with a wide field of view. The wide field of view allow for simultaneous multiorgan blood flow and oxygen consumption measurements.
Four positron emission tomography (PET) examinations are performed prior to the surgical procedure. The first PET examination (PET 1) is performed on the awake patient. The patient is then anesthetized, and the PET exam is repeated (PET 2). Vasopressor infusion is initiated and titrated to increase mean arterial blood pressure(MABP) above 60 mmHg, or by 10% relative to baseline(baseline MABP is measured prior to PET 2). The PET exam is repeated (PET 3). MABP is further increased to above 70 mmHg or by 20 % relative to the baseline level and the PET exam is repeated (PET 4). The anesthetized patient is then transported to the surgical theatre and surgery is initiated. During the surgical procedure, MABP is maintained between 70-80 mmHg according to institutional guidelines. The vasopressor infusion is terminated after completion of the surgery.. Invasive blood pressure, cardiac output (CO),depth of anesthesia (bispectral index) and brain tissue oxygen saturation(near infrared spectroscopy) are continuously measured.An MRI examination is performed 24 hours after surgery to detect any ischemic lesions possibly associated with the vasopressor infusion.
- The initial sample size of 40 patients was reduced to 32 patients in april 2024 (after inclusion of 4 patients). The change in sample size is due to unexpected limited scanner availability and unexpected difficuties with patient recruitment. These factors will be associated with a longer period of patient inclusion and consequently longer time before study completion which we find unacceptable.
** In a substudy including approximately half of the patients, we plan to describe the physiology of the circulatory system during the transition from wakefulness to general anesthesia. Specifically, we will present the absolute and relative changes in blood flow to the brain and selected non-cerebral organs. The analysis will also assess the redistribution of cardiac output during this transition.
This substudy is intended solely to describe physiological changes occurring during the transition from wakefulness to anesthesia. Only data obtained prior to the randomized part of the protocol will be used, and the substudy is independent of the randomized analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blinded, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Noradrenaline | Experimental | Drug: NoradrenalinNoradrenaline |
| Phenylephrine | Active comparator | Drug: PhenylephrinePhenylephrine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of supratentorial malignant or non-malignant brain tumors. Preferably 3 cm or larger( measured as the largest diameter in any plane on MRI).
- Scheduled for elective supratentorial craniotomy.
- Patients aged between 18 and 75 years.
- American Society of Anesthesiologists status 1-3
Key exclusion criteria (5 listed)
- History of allergy or intolerance to one of the study medications.
- Active treatment with monoamine oxidase inhibitors.
- An American Society of Anesthesiologists (ASA)physical status IV-VI.
- Pregnancy or breastfeeding.
- Inability to provide written informed consent -
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 |
|---|---|---|
| NoradrenalinAlso: NoradrenalineInfusion of noradrenaline during anesthesia and surgery | Drug | Noradrenaline |
| PhenylephrineAlso: metaoxedrinInfusion of phenylephrine during anesthesia and surgery | Drug | Phenylephrine |
Primary outcome
Cerebral blood flow
Time frame: Up to 3 hours (measured on the day of surgery prior to the surgical procedure)
Blood flow measured in milliliters per minute through selected regions of the brain as determined by Positron Emission Tomography
7 secondary outcomes
Cerebral metabolic rate of oxygen
Time frame: Up to 4 hours (measured on the day of surgery prior to the surgical procedure)
Blood flow through body organs in milliliters per minute as determined by Positron Emission Tomography
Time frame: Up to 4 hours (measured on the day of surgery prior to the surgical procedure)
Blood pumped out by the heart per minute (cardiac output)
Time frame: Up to one day
Ischemic lesions
Time frame: Up to 3 days
Cerebral tissue oxygen saturation
Time frame: Up to one day
Bispectral Index (BIS)
Time frame: Up to one day
Organ metabolic rate of Oxygen
Time frame: Up to 3 hours (measured on the day of surgery prior to the surgical procedure)
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 19 Mar 2026.
- Derived from this study: PubMed 40132839Faisal Mohamad N, Koch KU, Aanerud J, Meier K, Mikkelsen IK, Espelund US, Eriksen CF, Juul N, Alstrup KB, Jespersen B, Fries LM, Tankisi A, Dyrskog S, Cortnum SOS, Sindby AK, Borghammer P, Tolbod LP, Meng L, Korshoej AR, Rasmussen M. Impact of norepinephrine versus phenylephrine on brain circulation, organ blood flow and tissue oxygenation in anaesthetised patients with brain tumours: study protocol for a randomised controlled trial. BMJ Open. 2025 Mar 25;15(3):e095172. doi: 10.1136/bmjopen-2024-095172.
- Individual participant dataSharing planned: Yes. THe trial data may be shared upon request to the Investigator
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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.
Mads Rasmussen, MD, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Noradrenalin and Phenylephrine in people with Hypotension, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 5 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 19 Mar 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 Denmark. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Rasmussen (004529265713, mads.rasmussen@vest.rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood flow (time frame: Up to 3 hours (measured on the day of surgery prior to the surgical procedure)). 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 NCT06083948, which also lists 1 linked publication.
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 19 Mar 2026.