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    Clinical Trial Results:
    Vasculopathic Injury and Plasma as Endothelial Rescue in septic shock (SHOCK) trial

    Summary
    EudraCT number
    		 2017-000427-27
    Trial protocol
    		 DK  
    Global end of trial date
    17 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Feb 2022
    First version publication date
    09 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VIPER-SHOCK
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03092245
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet, Section for Transfusion Medicine, Capitol Region Blood Bank
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, DK-2100
    Public contact
    Jakob Stensballe, Section for Transfusion Medicine, Capitol Region Blood Bank, 45 35458587, jakob.stensballe@regionh.dk
    Scientific contact
    Jakob Stensballe, Section for Transfusion Medicine, Capitol Region Blood Bank, +45 35458587, jakob.stensballe@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
    03 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Apr 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy of OctaplasLG® administration as compared to crystalloids (standard of care) in patients with septic shock
    Protection of trial subjects
    All patients are admitted to the ICU and therefore in a hospital setting. Special safety markeres specially related to organfailure are observed during the study such as TACO and TRALI
    Background therapy
    		 All patients receive normal standard of care treatment at the ICU
    Evidence for comparator
    		 Comparator i standard of care
    Actual start date of recruitment
    18 Apr 2017
    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
    Denmark: 55
    Worldwide total number of subjects
    55
    EEA total number of subjects
    55
    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)
    16
    From 65 to 84 years
    38
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were screened for inclusion upon admission to the ICU with septic shock

    Pre-assignment
    Screening details
    		 Screenings criteria were: 18 years old or above, admitted to the ICU at Bispebjerg Hospital, fulfilling the cirteria for septic shock (defined as need for vasopressor and lactate above 2 mmol/l), need for mechanical ventilation, need for naradrenalin at 0,1 mcg/kg/min or above

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open label trail

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    OctaplasLG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage according to trial algorithm

    Arm title
    		 Standard of care
    Arm description
    		 The standard of care group will receive crystalloids as volumen support according to trail algorithm
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ringer acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    all types of crystalloids can be used. the most common type i ringer acetate.

    Number of subjects in period 1
    		Intervention arm Standard of care
    Started
    28
    27
    Completed
    20
    24
    Not completed
    8
    3
         Transferred to other hospital
    1
    -
         Error in microscan
    1
    1
         Died before 24 hours
    -
    2
         Died
    3
    -
         Protocol deviation
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 55 55
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 16 16
        From 65-84 years
    		 38 38
        85 years and over
    		 1 1
    Gender categorical
    Both male and female patients at 18 years old or above could be included
    Units: Subjects
        Female
    		 25 25
        Male
    		 30 30

    End points

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    End points reporting groups
    Reporting group title
    Intervention arm
    Reporting group description
    		 -

    Reporting group title
    Standard of care
    Reporting group description
    		 The standard of care group will receive crystalloids as volumen support according to trail algorithm

    Primary: Change in micorvascular perfusion

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    End point title
    		 Change in micorvascular perfusion
    End point description
    The data describe mean change/diffrence i microvascular perfusion from baseline to 24 hours between the 2 groups
    End point type
    Primary
    End point timeframe
    From baseline to 24 hours
    End point values
    		 Intervention arm Standard of care
    Number of subjects analysed
    28
    27
    Units: mm/mm2
    log mean (standard error)
        PPV
    -1.528 ( 1.101 )
    0 ( 0 )
        PVD
    -2.2931 ( 0.2479 )
    0 ( 0 )
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    Intervention arm v Standard of care
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Mortality at 24h

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    End point title
    		 Mortality at 24h
    End point description
    Number of death at 24 hours
    End point type
    Secondary
    End point timeframe
    mortality at 24 hours
    End point values
    		 Intervention arm Standard of care
    Number of subjects analysed
    28 [1]
    27 [2]
    Units: number
        Death
    3
    2
    Notes
    [1] - ITT analysis
    [2] - ITT analysis
    Statistical analysis title
    		 ITT mortality at 24h
    Comparison groups
    Intervention arm v Standard of care
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.747
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Mortality at day 30

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    End point title
    		 Mortality at day 30
    End point description
    number of deaths at day 30
    End point type
    Secondary
    End point timeframe
    Mortality at day 30
    End point values
    		 Intervention arm Standard of care
    Number of subjects analysed
    28 [3]
    27 [4]
    Units: number
        Death
    12
    7
    Notes
    [3] - ITT analysis
    [4] - ITT analysis
    Statistical analysis title
    		 ITT mortality at dag 30
    Comparison groups
    Intervention arm v Standard of care
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.25
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Until day 30
    Adverse event reporting additional description
    Only SAR and some SAE of special interests will be recorded at these patients are admitted to an ICU and therefore critical ill and will experience AE all the time without any benefit for safety issues. SAE/SAR are recorded based on the patients medical record.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    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: Only SAR and some SAE are recorded for these patients as these are admitted to the ICU. NO SAE or SAR are observed

    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
    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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