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    Clinical Trial Results:
    Influence of continuous administration of phenylephrine versus dobutamine on spinal oxygen saturation, measured with near-infrared spectroscopy (NIRS).

    Summary
    EudraCT number
    		 2018-003687-31
    Trial protocol
    		 BE  
    Global end of trial date
    10 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jun 2024
    First version publication date
    07 Jun 2024
    Other versions
    Summary report(s)
    		 Final Study Report
    End Of Trial
    Protocol

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2018/005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Ghent
    Sponsor organisation address
    C. Heymanslaan 10, Gent, Belgium, 9000
    Public contact
    HIRUZ, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    HIRUZ, Ghent University Hospital, 093320000 93320500, hiruz.ctu@uzgent.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 May 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the effect of continuous administration of phenylephrine or dobutamine on the spinal vasculature, by measuring spinal oxygen saturation with NIRS.
    Protection of trial subjects
    See attachments
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jul 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    36
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 See attachments

    Pre-assignment
    Screening details
    		 See attachments

    Period 1
    Period 1 title
    Main period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    see attachments

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phenylephrine continuous infusion
    Arm description
    		 Phenylephrine continuous infusion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Phenylephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    See attachment

    Arm title
    		 Dobutamine continuous infusion
    Arm description
    		 Dobutamine continuous infusion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dobutamine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    See attachment

    Number of subjects in period 1 [1]
    		Phenylephrine continuous infusion Dobutamine continuous infusion
    Started
    17
    17
    Completed
    17
    17
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: In total, 36 patients signed an informed consent (replacement of 2 drop-outs).

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Phenylephrine continuous infusion
    Reporting group description
    		 Phenylephrine continuous infusion

    Reporting group title
    Dobutamine continuous infusion
    Reporting group description
    		 Dobutamine continuous infusion

    Primary: Primary

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    End point title
    		 Primary [1]
    End point description
    Spinal oxygen saturation measured by NIRS
    End point type
    Primary
    End point timeframe
    During the study
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: See attachments
    End point values
    		 Phenylephrine continuous infusion Dobutamine continuous infusion
    Number of subjects analysed
    17
    17
    Units: NIRS
        number (not applicable)
    17
    17
    No statistical analyses for this end point

    Secondary: Secondary

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    End point title
    		 Secondary
    End point description
    Cerebral oxygen saturation Deltoid muscle oxygen saturation
    End point type
    Secondary
    End point timeframe
    During the study
    End point values
    		 Phenylephrine continuous infusion Dobutamine continuous infusion
    Number of subjects analysed
    17
    17
    Units: oxygen saturation
        number (not applicable)
    17
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the study
    Adverse event reporting additional description
    See attachments
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: See attachments

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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