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    Clinical Trial Results:
    Evaluation of patients after cardiac surgery: Novel ultrasound parameters for quantification of renal perfusion & analysis of phenylephrines’ effect on invasive haemodynamics and echocardiographic measures.

    Summary
    EudraCT number
    		 2020-000573-25
    Trial protocol
    		 DK  
    Global end of trial date
    31 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2023
    First version publication date
    04 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1.1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04419662
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
    Public contact
    Department of Anaesthesia, Aarhus University Hospital, 45 27208913, petejuhl@rm.dk
    Scientific contact
    Department of Anaesthesia, Aarhus University Hospital, 45 50736322, johanfhermansen@gmail.com
    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
    06 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the haemodynamic effects of phenylephrine Please see https://pubmed.ncbi.nlm.nih.gov/35230558/ for detailed results or contact the corresponding author: johan.hermansen@rm.dk for questions or elaborations on results. This small phase-4 study was safe and with no serious adverse events or suspected events related to the study.
    Protection of trial subjects
    Patients remained sedated in study period (after surgery; as per local standard)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    9
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 31
    Number of subjects completed
    		 31

    Period 1
    Period 1 title
    Phenylephrine
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Phenylephrine and changen in PEEP and position
    Arm description
    		 Changes in positive end-expiratory pressure and position, and afterwards in mean arterial pressure induced by infusion of phenylephrine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    phenylephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Phenylephrine 1 mg/ml at incremental infusion rates, maximum of 1 ug/kg/min

    Number of subjects in period 1
    		Phenylephrine and changen in PEEP and position
    Started
    31
    Completed
    31
    Period 2
    Period 2 title
    Before/after phenylephrine
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Before/after phenylephrine
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Before/after phenylephrine
    Started
    31
    Before/after phenylephrine
    31
    Completed
    31

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phenylephrine
    Reporting group description
    		 -

    Reporting group values
    		 Phenylephrine Total
    Number of subjects
    		 31 31
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 68 (62 to 72) -
    Gender categorical
    Cannot change to make numbers add uo. The section is locked by the system.
    Units: Subjects
        Female
    		 3 3
        Male
    		 28 28
    Subject analysis sets

    Subject analysis set title
    Phenylephrine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients

    Subject analysis sets values
    		 Phenylephrine
    Number of subjects
    31
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    Gender categorical
    Cannot change to make numbers add uo. The section is locked by the system.
    Units: Subjects
        Female
    2
        Male
    29

    End points

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    End points reporting groups
    Reporting group title
    Phenylephrine and changen in PEEP and position
    Reporting group description
    		 Changes in positive end-expiratory pressure and position, and afterwards in mean arterial pressure induced by infusion of phenylephrine.
    Reporting group title
    Before/after phenylephrine
    Reporting group description
    		 -

    Subject analysis set title
    Phenylephrine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients

    Primary: Resistive index

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    End point title
    		 Resistive index
    End point description
    View link for more details
    End point type
    Primary
    End point timeframe
    1 hour
    End point values
    		 Phenylephrine and changen in PEEP and position Before/after phenylephrine Phenylephrine
    Number of subjects analysed
    31
    31
    31
    Units: noon unit
        median (confidence interval 95%)
    0.63 (0.61 to 0.66)
    0.64 (0.62 to 0.67)
    0.64 (0.62 to 0.67)
    Attachments
    		 Untitled (Filename: table.png)
    Untitled (Filename: table 2.png)
    Statistical analysis title
    		 Mixed models analysis
    Comparison groups
    Phenylephrine and changen in PEEP and position v Before/after phenylephrine
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [1] - Patient characteristics are presented as medians (interquartile range (IQR)) or proportions (percentage). A repeated measures multilevel mixed-effects linear regression model with an interaction term between PEEP and position was used for the first part of the study and for phenylephrine infusion ind the second part of the study. Marginal means or medians (with 95% confidence interval (95% CI)) and effects of PEEP, position and phenylephrine were calculated in the model.

    Secondary: RVSI

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    End point title
    		 RVSI
    End point description
    View link for more details
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 Phenylephrine
    Number of subjects analysed
    31
    Units: noon unit
        median (confidence interval 95%)
    0.16 (0.11 to 0.21)
    No statistical analyses for this end point

    Secondary: PPF

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    End point title
    		 PPF
    End point description
    View link for more details
    End point type
    Secondary
    End point timeframe
    1 hour
    End point values
    		 Phenylephrine
    Number of subjects analysed
    31
    Units: noon unit
        median (confidence interval 95%)
    0.18 (0.16 to 0.20)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    1 day
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Phenylephrine
    Reporting group description
    		 One patient was on an x-ray taken before the study found to have an infiltrate that had to be followed. On follow-up this was not suspected to be malignant. No further actions were taken.

    Serious adverse events
    		 Phenylephrine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Phenylephrine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 31 (3.23%)
    Respiratory, thoracic and mediastinal disorders
    Chest X-ray abnormal
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences all number
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35230558
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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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