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    Clinical Trial Results:
    Requirement of Skeletal Muscle Paralysis in Hypothermic Patients after Cardiac Arrest. A pilot study

    Summary
    EudraCT number
    		 2009-015771-27
    Trial protocol
    		 AT  
    Global end of trial date
    12 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Oct 2020
    First version publication date
    07 Oct 2020
    Other versions
    Summary report(s)
    		 Relax_Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    V3
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01719770
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Vienna, Emergemcy Medicine
    Sponsor organisation address
    Währinger Gürtel 18-20, Vienna, Austria, 1090 Wien
    Public contact
    Emergency Department, Medical University Vienna, Emergency Department, Medical University Vienna, +43 14040039530, heidrun.losert@meduniwien.ac.at
    Scientific contact
    Emergency Department, Medical University Vienna, Emergency Department, Medical University Vienna, +43 14040039530,
    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
    12 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Number of shivering episodes will be assessed and compared between the two groups with the Shivering Assessment Scale and the EMG.
    Protection of trial subjects
    Intensive Care Patients were treated as usually, no painful or distressing examinations were done in these fully sedated, intubated patients.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2010
    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
    Austria: 63
    Worldwide total number of subjects
    63
    EEA total number of subjects
    63
    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)
    39
    From 65 to 84 years
    22
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients with out of hospital cardiac arrest older than 18 years who presented to the emergency department with sustained return of spontaneous circulation who remained comatose.

    Pre-assignment
    Screening details
    		 Cardiac arrest had to be of presumed cardiopulmonary origin. Core body temperature had to be equal or above 35°C.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Data analyst, Subject, Assessor, Carer
    Blinding implementation details
    A sealed envelope was opened by a nurse not involved in the treatment of the patient or the study. This person prepared the blinded anti-shivering bolus and continuous medication (neuromuscular blockers or saline)

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Continuous-NMB-group
    Arm description
    		 This group received a continuous rocuronium infusion and in case of shivering an saline bolus
    Arm type
    		 Experimental

    Investigational medicinal product name
    rocuronium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25mg/kg/h

    Arm title
    		 Bolus-NMB-group
    Arm description
    		 Patients received saline infusion and in case of shivering a rocuronium bolus
    Arm type
    		 Active comparator

    Investigational medicinal product name
    rocuronium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    0.025ml/kg in case of shivering

    Number of subjects in period 1
    		Continuous-NMB-group Bolus-NMB-group
    Started
    32
    31
    Completed
    32
    31

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Continuous-NMB-group
    Reporting group description
    		 This group received a continuous rocuronium infusion and in case of shivering an saline bolus

    Reporting group title
    Bolus-NMB-group
    Reporting group description
    		 Patients received saline infusion and in case of shivering a rocuronium bolus

    Reporting group values
    		 Continuous-NMB-group Bolus-NMB-group Total
    Number of subjects
    		 32 31 63
    Age categorical
    Only adults were included
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 19 19 38
        From 65-84 years
    		 11 12 23
        85 years and over
    		 2 0 2
    Age continuous
    Only adult patients were included in the study
    Units: years
        arithmetic mean (standard deviation)
    		 62 ( 13 ) 58 ( 11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 5 11
        Male
    		 26 26 52

    End points

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    End points reporting groups
    Reporting group title
    Continuous-NMB-group
    Reporting group description
    		 This group received a continuous rocuronium infusion and in case of shivering an saline bolus

    Reporting group title
    Bolus-NMB-group
    Reporting group description
    		 Patients received saline infusion and in case of shivering a rocuronium bolus

    Primary: subjects with shivering episodes

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    End point title
    		 subjects with shivering episodes
    End point description
    Percentage of patients with shivering episodes
    End point type
    Primary
    End point timeframe
    study period
    End point values
    		 Continuous-NMB-group Bolus-NMB-group
    Number of subjects analysed
    32
    31
    Units: number of patients
        Percentage
    8
    29
    Statistical analysis title
    		 primary analysis patients with shivering episodes
    Comparison groups
    Continuous-NMB-group v Bolus-NMB-group
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: number of shivering episodes

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    End point title
    		 number of shivering episodes
    End point description
    Median shivering episodes per group were reported
    End point type
    Secondary
    End point timeframe
    whole study period
    End point values
    		 Continuous-NMB-group Bolus-NMB-group
    Number of subjects analysed
    32
    31
    Units: median number of shivering episodes
    0
    8
    Statistical analysis title
    		 number of shivering episodes
    Comparison groups
    Bolus-NMB-group v Continuous-NMB-group
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Doses of midazolam

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    End point title
    		 Doses of midazolam
    End point description
    End point type
    Secondary
    End point timeframe
    whole study period
    End point values
    		 Continuous-NMB-group Bolus-NMB-group
    Number of subjects analysed
    32
    31
    Units: mg/kg
        geometric mean (standard deviation)
    4.3 ( 0.8 )
    5.1 ( 0.9 )
    No statistical analyses for this end point

    Secondary: Doses of fentanyl

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    End point title
    		 Doses of fentanyl
    End point description
    End point type
    Secondary
    End point timeframe
    whole study period
    End point values
    		 Continuous-NMB-group Bolus-NMB-group
    Number of subjects analysed
    32
    31
    Units: mg/kg
        geometric mean (standard deviation)
    0.062 ( 0.014 )
    0.071 ( 0.007 )
    No statistical analyses for this end point

    Secondary: Cumulative doses of rocuronium

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    End point title
    		 Cumulative doses of rocuronium
    End point description
    End point type
    Secondary
    End point timeframe
    whole study period
    End point values
    		 Continuous-NMB-group Bolus-NMB-group
    Number of subjects analysed
    32
    31
    Units: mg/kg
        geometric mean (standard deviation)
    7.8 ( 1.8 )
    2.3 ( 1.6 )
    No statistical analyses for this end point

    Secondary: Overall mortality

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    End point title
    		 Overall mortality
    End point description
    End point type
    Secondary
    End point timeframe
    whole study period
    End point values
    		 Continuous-NMB-group Bolus-NMB-group
    Number of subjects analysed
    32
    31
    Units: number of patients
    15
    12
    No statistical analyses for this end point

    Secondary: Rate of favorable neurologic function after 12 months

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    End point title
    		 Rate of favorable neurologic function after 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    whole study period
    End point values
    		 Continuous-NMB-group Bolus-NMB-group
    Number of subjects analysed
    32
    31
    Units: Number of patients
    17
    17
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    whole study period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Bolus Neuromuscular Blocker Group
    Reporting group description
    		 -

    Reporting group title
    Continuous Neuromuscular Blocker Group
    Reporting group description
    		 -

    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
    Serious adverse events
    		 Bolus Neuromuscular Blocker Group Continuous Neuromuscular Blocker Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 31 (3.23%)
    1 / 32 (3.13%)
         number of deaths (all causes)
    12
    15
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
    Additional description: After out of hospital cardiopulmonary resuscitation a serial rib fracture caused a pneumothorax, which had to be treated with a drainage This is a common complication of cardiopulmonary reanimation and was not related with the study.
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematothorax
    Additional description: Patient received routinely a central venous catheter - after 50 hours, a haematothorax after a mispunction of the left Artery subclavia appeared A thoracic Augean had to overstich the artery. This was not related to the study.
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Bolus Neuromuscular Blocker Group Continuous Neuromuscular Blocker Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 32 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2010
    The dosage of continuous rocuronium was adapted lower levels EMG will not be performed, only shivering assessment scale stress hormone levels will not be measured

    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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