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    Clinical Trial Results:
    Effect of preoperative intravenous highdose methylprednisolone on orthostatic intolerance, sleeping pattern, glucose homeostasis and immune signaling in patients scheduled for total hip-arthroplasty

    Summary
    EudraCT number
    		 2015-000102-19
    Trial protocol
    		 DK  
    Global end of trial date
    02 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 May 2022
    First version publication date
    22 May 2022
    Other versions
    Summary report(s)
    		 Orthostatic hypotension and intolerance

    Trial information

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    Trial identification
    Sponsor protocol code
    HL_VL_01_2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02445898
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Copenhagen university Hospital Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Viktoria Oline Lindberg-Larsen, Section for Surgical Pathophysiology, Rigshospitalet, 0045 28791991, viktoria_oline@hotmail.com
    Scientific contact
    Viktoria Oline Lindberg-Larsen, Section for Surgical Pathophysiology, Rigshospitalet, 0045 28791991, viktoria_oline@hotmail.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
    01 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of intravenous highdose injection of methylprednisolone on orthostatic hypotension and intolerance in patients undergoing total hip-arthroplasty
    Protection of trial subjects
    All trial patients followed standard treatment regarding surgery and postoperative regime. Information regarding physical testing and extra blood sampling was given prior til inclusion.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2015
    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: 59
    Worldwide total number of subjects
    59
    EEA total number of subjects
    59
    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)
    20
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patient were recruited at the ambulatory at Bispebjerg University Hospital visit when planned for total hip arthroplasty surgery. 190 patients were screened for inclusion, 64 patients were included, and 59 patients completed the study. The 5 patients excluded the trial due to protocol violations, primarily conversion to general anesthesia.

    Pre-assignment
    Screening details
    		 • Age 55-80 years • Hip osteoarthrosis • Planned for primary total hip arthroplasty (THA) • Able to speak and understand Danish • Have given informed consent

    Pre-assignment period milestones
    Number of subjects started
    		 59
    Number of subjects completed
    		 59

    Period 1
    Period 1 title
    Intervention period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Carer, Assessor
    Blinding implementation details
    A research assistant not otherwise involved in the trial performed a computer-generated random allocation sequence (1:1 allocation rate) concealed in 64 consecutively numbered, opaque, sealed envelopes determining active treatment or placebo. On the morning of surgery the envelopes were opened consecutively, and the trial drug was prepared by 2 anesthetist nurses not otherwise involved in the collection of trial data.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Isotonic saline (2 mL)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Isotonic saline
    Investigational medicinal product code
    PL1
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    2 mL isotonic saline administered IV after induction af anaesthesia

    Arm title
    		 Steroid
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Solu-Medrol
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    125 mg Solu-Medrol administered IV after induction af anaesthesia

    Number of subjects in period 1
    		Placebo Steroid
    Started
    30
    29
    Completed
    30
    29

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Isotonic saline (2 mL)

    Reporting group title
    Steroid
    Reporting group description
    		 -

    Reporting group values
    		 Placebo Steroid Total
    Number of subjects
    		 30 29 59
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.2 ( 6.7 ) 67.4 ( 5.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 12 17 29
        Male
    		 18 12 30
    ASA
    Units: Subjects
        ASA1
    		 6 6 12
        ASA2
    		 24 22 46
        ASA3
    		 0 1 1
    BMI
    Units: BMI
        arithmetic mean (standard deviation)
    		 27.5 ( 4.3 ) 26.9 ( 4.1 ) -
    Hemoglobin
    Units: g/dL
        arithmetic mean (standard deviation)
    		 8.7 ( 0.6 ) 8.7 ( 0.7 ) -
    C-reactive protein
    Units: mg/l
        median (inter-quartile range (Q1-Q3))
    		 2.5 (1.0 to 4.0) 1.0 (1.0 to 3.0) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Isotonic saline (2 mL)

    Reporting group title
    Steroid
    Reporting group description
    		 -

    Primary: Orthostatic hypotension 6 hrs

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    End point title
    		 Orthostatic hypotension 6 hrs
    End point description
    End point type
    Primary
    End point timeframe
    Orthostatic challenge 6 hrs postoperatively
    End point values
    		 Placebo Steroid
    Number of subjects analysed
    30
    29
    Units: project patients
        OH
    11
    11
    Statistical analysis title
    		 RR
    Comparison groups
    Placebo v Steroid
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Orthostatic intolerance 6 hrs

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    End point title
    		 Orthostatic intolerance 6 hrs
    End point description
    End point type
    Secondary
    End point timeframe
    Orthostatic challenge 6 hrs postoperatively
    End point values
    		 Placebo Steroid
    Number of subjects analysed
    30
    29
    Units: project patients
        OI
    13
    9
    Statistical analysis title
    		 RR
    Comparison groups
    Placebo v Steroid
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Orthostatic hypotension 24 hrs

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    End point title
    		 Orthostatic hypotension 24 hrs
    End point description
    End point type
    Secondary
    End point timeframe
    Orthostatic challenge 24 hrs postoperatively
    End point values
    		 Placebo Steroid
    Number of subjects analysed
    30
    29
    Units: project patients
        OH
    5
    2
    Statistical analysis title
    		 RR
    Comparison groups
    Placebo v Steroid
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Orthostatic intolerance 24 hrs

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    End point title
    		 Orthostatic intolerance 24 hrs
    End point description
    End point type
    Secondary
    End point timeframe
    Orthostatic challenge 24 hrs postoperatively
    End point values
    		 Placebo Steroid
    Number of subjects analysed
    30
    29
    Units: project patients
        OI
    5
    1
    Statistical analysis title
    		 RR
    Comparison groups
    Placebo v Steroid
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From time of trial medication administration until 20 hrs after administration (5 x T½)
    Adverse event reporting additional description
    Following postoperative conditions will not be registered ad AEs, as they are common following anaesthesia and surgery: Moderate hypotension (MAP <60 mmHg) Shivering Pain from the surgical field Urine retention Intraoperative bleeding nausea and vomiting Dizziness Fatigue
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Frequency threshold for reporting non-serious adverse events: 2%
    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 adverse events in the small clinical trial

    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/29573263
    http://www.ncbi.nlm.nih.gov/pubmed/32719355
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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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