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    Clinical Trial Results:
    Evaluation of FLuid REsuscitation with Sterofundin ® ISO (Ringerfundin), Plasma-Lyte® or NaCl 0.9%. (FluReS study)

    Summary
    EudraCT number
    		 2014-001005-41
    Trial protocol
    		 BE  
    Global end of trial date
    29 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jun 2024
    First version publication date
    07 Jun 2024
    Other versions
    Summary report(s)
    		 Final Study Report
    End Of Trial
    Doc A
    Protocol

    Trial information

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    Trial identification
    Sponsor protocol code
    FluReS study
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Department of Anaesthethics, Ghent University Hospital, +32 93322142, Freekje.Viaene@gmail.com
    Scientific contact
    Department of Anaesthethics, Ghent University Hospital, +32 93322142, Freekje.Viaene@gmail.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
    09 Oct 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary: Evaluate impact of fluid bolus with 1 L of Sterofundin, Plasma-Lyte ® and NaCl0.9 on acid-base status according to Stewart (SIDa and SIG).
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jul 2015
    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
    Belgium: 99
    Worldwide total number of subjects
    99
    EEA total number of subjects
    99
    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)
    99
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 99 patients were included in the experimetal arms starting from 17-Jul-2015. End of trial notification was dated 29-Jan-2016 and submitted to EC and CA on 19-May-2017

    Pre-assignment
    Screening details
    		 Inclusion Criteria: 1. Informed consent patient or legal representative 2. Treating physician decided for fluid bolus of 1 L administered over a 30-60 min time period. 3. Arterial catheter and urinary catheter.

    Period 1
    Period 1 title
    Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sterofundin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sterofundin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intravesical solution
    Routes of administration
    Solution for infusion
    Dosage and administration details
    see attachments

    Arm title
    		 Plasmalyte
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Plasmalyte
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Intravesical solution
    Routes of administration
    Solution for infusion
    Dosage and administration details
    see attachments

    Number of subjects in period 1
    		Sterofundin Plasmalyte
    Started
    52
    47
    Completed
    52
    47

    Baseline characteristics

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

    Reporting group values
    		 Trial Total
    Number of subjects
    		 99 99
    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)
    		 99 99
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 99 99
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Sterofundin
    Reporting group description
    		 -

    Reporting group title
    Plasmalyte
    Reporting group description
    		 -

    Primary: change in chloride concentration

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    End point title
    		 change in chloride concentration [1]
    End point description
    End point type
    Primary
    End point timeframe
    During the study
    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: See attachment
    End point values
    Number of subjects analysed
    Units: percentage
        number (not applicable)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    overall trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    sterofundin group
    Reporting group description
    		 Patients randomised to this group received sterofundin

    Reporting group title
    plasmalyte group
    Reporting group description
    		 Patients randomised to this group received Plasmalyte

    Serious adverse events
    		 sterofundin group plasmalyte group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 47 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 sterofundin group plasmalyte group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 47 (0.00%)
    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 non-SAE's were recorded for these results

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Mar 2015
    Addition of a 3rd treatment: Plasmalyte

    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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