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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • Aarhus University Hospital

    Aarhus, 8200

    Mads Rasmussen, MD, PhD, +4529265713, mads.rasmussen@vest.rm.dk

    Recruiting

Other trials in Denmark

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 groups in NCT06083948
Study groupRoleWhat they receive
NoradrenalineExperimentalNoradrenaline
Receives: Drug: Noradrenalin
PhenylephrineActive comparatorPhenylephrine
Receives: Drug: Phenylephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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)

  2. 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)

  3. 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

  4. Ischemic lesions

    Ischemic lesions possibly associated with vasopressor use as detected on the postoperative MRI examination

    Measured: Up to 3 days

  5. Cerebral tissue oxygen saturation

    Cerebral tissue oxygen saturation as measured with near infrared spectroscopy (NIRS)

    Measured: Up to one day

  6. Bispectral Index (BIS)

    Depth of anesthesia as measured by BIS

    Measured: Up to one day

  7. 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.

  1. First posted16 Oct 2023
  2. Study start20 Dec 2023
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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)
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

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.

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