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Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia (IMPACT)

Primary Purpose

Hypotension

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Noradrenalin
Phenylephrine
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Noradrenaline

    Phenylephrine

    Arm Description

    Noradrenaline

    Phenylephrine

    Outcomes

    Primary Outcome Measures

    Cerebral blood flow
    Blood flow measured in milliliters per minute through selected regions of the brain as determined by Positron Emission Tomography

    Secondary Outcome Measures

    Cerebral metabolic rate of oxygen
    Cerebral oxygen consumption in selected regions of the brain as determined by Positron Emission Tomography
    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
    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
    Ischemic lesions
    Ischemic lesions possibly associated with vasopressor use as detected on the postoperative MRI examination
    Cerebral tissue oxygen saturation
    Cerebral tissue oxygen saturation as measured with near infrared spectroscopy (NIRS)
    Bispectral Index (BIS)
    Depth of anesthesia as measured by BIS
    Organ metabolic rate of Oxygen
    Oxygen consumption in various organs as measured by Positron Emission Tomography

    Full Information

    First Posted
    September 26, 2023
    Last Updated
    October 23, 2023
    Sponsor
    University of Aarhus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06083948
    Brief Title
    Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia
    Acronym
    IMPACT
    Official Title
    Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia in Neurosurgical Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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 40 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 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized, double blinded, clinical trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Noradrenaline
    Arm Type
    Experimental
    Arm Description
    Noradrenaline
    Arm Title
    Phenylephrine
    Arm Type
    Active Comparator
    Arm Description
    Phenylephrine
    Intervention Type
    Drug
    Intervention Name(s)
    Noradrenalin
    Other Intervention Name(s)
    Noradrenaline
    Intervention Description
    Infusion of noradrenaline during anesthesia and surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Phenylephrine
    Other Intervention Name(s)
    metaoxedrin
    Intervention Description
    Infusion of phenylephrine during anesthesia and surgery
    Primary Outcome Measure Information:
    Title
    Cerebral blood flow
    Description
    Blood flow measured in milliliters per minute through selected regions of the brain as determined by Positron Emission Tomography
    Time Frame
    Up to 3 hours (measured on the day of surgery prior to the surgical procedure)
    Secondary Outcome Measure Information:
    Title
    Cerebral metabolic rate of oxygen
    Description
    Cerebral oxygen consumption in selected regions of the brain as determined by Positron Emission Tomography
    Time Frame
    Up to 4 hours (measured on the day of surgery prior to the surgical procedure)
    Title
    Blood flow through body organs in milliliters per minute as determined by Positron Emission Tomography
    Description
    Blood flow in various body organs supplied by the systemic circulation
    Time Frame
    Up to 4 hours (measured on the day of surgery prior to the surgical procedure)
    Title
    Blood pumped out by the heart per minute (cardiac output)
    Description
    Cardiac output as determined by Positron Emission Tomography and/or by beat-to-beat determination by analysis of the arterial blood pressure waveform
    Time Frame
    Up to one day
    Title
    Ischemic lesions
    Description
    Ischemic lesions possibly associated with vasopressor use as detected on the postoperative MRI examination
    Time Frame
    Up to 3 days
    Title
    Cerebral tissue oxygen saturation
    Description
    Cerebral tissue oxygen saturation as measured with near infrared spectroscopy (NIRS)
    Time Frame
    Up to one day
    Title
    Bispectral Index (BIS)
    Description
    Depth of anesthesia as measured by BIS
    Time Frame
    Up to one day
    Title
    Organ metabolic rate of Oxygen
    Description
    Oxygen consumption in various organs as measured by Positron Emission Tomography
    Time Frame
    Up to 3 hours (measured on the day of surgery prior to the surgical procedure)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 -

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    THe trial data may be shared upon request to the Investigator
    IPD Sharing Time Frame
    Other researchers may request the data after publication of the primary results and for a period of 10 years
    IPD Sharing Access Criteria
    No specific criteria

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    Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia

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