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    Clinical Trial Results:
    Effect of high versus low dose intravenous dexamethason on complications in the immediate postoperative setting after nephrectomy- a randomized, double-blind, controlled trial

    Summary
    EudraCT number
    		 2017-000505-20
    Trial protocol
    		 DK  
    Global end of trial date
    03 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Feb 2020
    First version publication date
    29 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DEXNEF01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eske K Aasvang
    Sponsor organisation address
    blegdamsvej 9, copenhagen, Denmark,
    Public contact
    Kristin Julia Steinthorsdottir, Rigshospitalet, 0045 31666112, kristin.julia.steinthorsdottir.01@regionh.dk
    Scientific contact
    Kristin Julia Steinthorsdottir, Rigshospitalet, 0045 31666112, kristin.julia.steinthorsdottir.01@regionh.dk
    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
    20 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Dec 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the effect of high versus low dose intravenous dexamethasone on complications in the immediate postoperative setting after nephrectomy, heminephrectomy. Main objective complications demanding treatment in the post anaesthesia care unit (PACU) (pain, nausea).
    Protection of trial subjects
    Trial subjects followed standard procedures. There was no extra distress or discomfort related to the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Apr 2017
    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: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    19
    From 65 to 84 years
    21
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 at preoperative appointment

    Pre-assignment
    Screening details
    		 lægelig vurdering

    Period 1
    Period 1 title
    overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 8 mg dexamethasone
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    8 mg iv bolus

    Arm title
    		 24 mg dexamethasone
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    24 mg iv bolus

    Number of subjects in period 1
    		8 mg dexamethasone 24 mg dexamethasone
    Started
    19
    22
    Completed
    19
    22

    Baseline characteristics

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

    Reporting group values
    		 overall Total
    Number of subjects
    		 41 41
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 18 18
        From 65-84 years
    		 22 22
        85 years and over
    		 1 1
        all
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 67 (58 to 74) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 31 31
    height
    Units: cm
        arithmetic mean (standard deviation)
    		 178 ( 8 ) -
    weight
    Units: kg
        arithmetic mean (standard deviation)
    		 89 ( 18 ) -

    End points

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    End points reporting groups
    Reporting group title
    8 mg dexamethasone
    Reporting group description
    		 -

    Reporting group title
    24 mg dexamethasone
    Reporting group description
    		 -

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint
    End point description
    Any complications (YES/NO) in the post-anesthesia care unit
    End point type
    Primary
    End point timeframe
    hours
    End point values
    		 8 mg dexamethasone 24 mg dexamethasone
    Number of subjects analysed
    19
    22
    Units: patients
        YES
    13
    18
        NO
    6
    2
        missing
    0
    2
    Statistical analysis title
    		 chi-square test
    Comparison groups
    8 mg dexamethasone v 24 mg dexamethasone
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.127
    Method
    		 Chi-squared corrected
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.241
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.042
         upper limit
    		 1.388

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    60 hours from administration of study drug
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 non used (no AE)
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: There were no non-serious adverse events recorded withj a frequency>5%

    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.
    The trial was ended prematurely due to recruitment problems. Therefore only primary endpoint is reported. There were no differences between groups.
    For support, Contact us.
    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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