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    Clinical Trial Results:
    Do use of torniquete reduce the impact of the antibiotic treatment during orthopedic treatment?

    Summary
    EudraCT number
    		 2018-000217-21
    Trial protocol
    		 DK  
    Global end of trial date
    29 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Feb 2021
    First version publication date
    08 Feb 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    310816
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    Pelle Hanberg, Horsens Regional Hospital, 0045 28744852, pellehanberg@clin.au.dk
    Scientific contact
    Pelle Hanberg, Horsens Regional Hospital, 0045 28744852, pellehanberg@clin.au.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
    30 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this trial is to asses the penetration of cefuroxime into muscle, subcutaneous and bone tissue using the pharmacokinetic tool microdialysis, and to see how the use of torniquete affects the penetration and the ischaemic markers. The primary endpoints are the time for which the cefuroxime concentration is maintained above the minimal inhibitory concentration (T>MIC), penetrations ratios and the iscaemic markers. Secondary endpoints are standard pharmacokinetic parameters (eg. half-life, Cmax, Tmax and AUC).
    Protection of trial subjects
    No patients experience any discomforts with the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2018
    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: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    7
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 medical evaluation

    Pre-assignment
    Screening details
    		 In- and excluding criteria has to be fulfilled before assignment to the study

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 over all
    Arm description
    		 All subjects received 1500 mg cefuroxime x 2 with an 6 hours interval.
    Arm type
    		 All subjects recieved the same amount of drug

    Investigational medicinal product name
    Cefuroxime
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1500 mg x 2 given intravenously over 10 min

    Number of subjects in period 1
    		over all
    Started
    10
    Completed
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 overall trial (overall period) Total
    Number of subjects
    		 10 10
    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)
    		 7 7
        From 65-84 years
    		 3 3
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    over all
    Reporting group description
    		 All subjects received 1500 mg cefuroxime x 2 with an 6 hours interval.

    Primary: T>MIC (4 microgram/ml)

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    End point title
    		 T>MIC (4 microgram/ml) [1]
    End point description
    The time with concentrations above the minimal inhibitory concentration (T>MIC) (4 µg/mL) in min for plasma, subcutaneous tissue, skeletal muscle, and calcaneal cancellous bone on both the tourniquet and non-tourniquet leg from time 0-6 h
    End point type
    Primary
    End point timeframe
    0-6 h of sampling
    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: Please find "T>MIC (4 microgram/ml)"
    End point values
    		 over all
    Number of subjects analysed
    10
    Units: minute
        arithmetic mean (confidence interval 95%)
    0 (0 to 0)
    Attachments
    		 T>MIC (4 microgram/ml)
    No statistical analyses for this end point

    Primary: ischemic metabolites ratio

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    End point title
    		 ischemic metabolites ratio [2]
    End point description
    The mean concentration difference (%) of ischemic metabolites between the tourniquet-exposed and non-tourniquet-exposed leg (tourniquet/non-tourniquet).
    End point type
    Primary
    End point timeframe
    0-12 h from sampling
    Notes
    [2] - 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: Please find "ischemic metabolites ratio"
    End point values
    		 over all
    Number of subjects analysed
    10
    Units: percent
        arithmetic mean (confidence interval 95%)
    0 (0 to 0)
    Attachments
    		 ischemic metabolites ratio
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    from placement of the microdialysis catheter until the last collected blood sample.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 produktresume
    Dictionary version
    21. marts
    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: No adverse events.

    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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