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    Clinical Trial Results:
    Hemodynamic effects from administration of body temperature warmed versus room temperature fluid boluses in healthy volunteers

    Summary
    EudraCT number
    		 2016-002548-18
    Trial protocol
    		 SE  
    Global end of trial date
    11 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jun 2022
    First version publication date
    16 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Studie1hemodynami
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03209271
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Karolinska Institutet Södersjukhuset
    Sponsor organisation address
    Sjukhusbacken 10, Stockholm, Sweden, 118 83
    Public contact
    KI SÖS, Karolinska Institutet Södersjukhuset, +46 8616 29 35,
    Scientific contact
    KI SÖS, Karolinska Institutet Södersjukhuset, +46 8616 29 35,
    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 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the difference in cardiac output between the two groups
    Protection of trial subjects
    All trial subjects were screened for comorbidites and were all classified as ASA score I, meaning only subjects without previous medical issues were included, and only non-pregnant adults were considered for inclusion. All subjects were informed beforehand and gave written and oral consent to participation. All subjects were monitored during the trial for blood pressure, heart rate, temperature, cardiac output and saturation and were monitored by trained staff. The trial intervention is an intravenous fluid that is well know and has been extensively used with small risks in daily practice in healthy adults. Any incidents corresponding to known AE, SAE or SUSAR were monitored for and would be reported (theoretically anaphylaxis or respiratory issues. None were detected.
    Background therapy
    		 None
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2017
    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
    Sweden: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    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)
    21
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was conducted from February 1 2017 in Stockholm, Sweden to March 28 2017

    Pre-assignment
    Screening details
    		 Inclusion criteria: 18 years or older and no significant health issues. Exclusion criteria: ASA classification of 2 or above or known pregnancy. Cross-over format where each subject was randomized to receive either controll or intervention on their first visit, and the other on their second after >24hours washout.

    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
    Blinding was not possible or meaningful since the outcomes were objective measurements, the subjects would clearly be able to tell the temperature infused when the infusion started, and the staff would be able to tell from the equipment if the fluid was cooled or warmed.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Body temperature
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ringers Acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    500ml administered intravenously via pump over 15 minutes

    Arm title
    		 Room temperature
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ringers Acetate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    500ml administered intravenously via pump over 15 minutes

    Number of subjects in period 1
    		Body temperature Room temperature
    Started
    21
    21
    Completed
    21
    20
    Not completed
    0
    1
         Data retrieval issue
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Body temperature
    Reporting group description
    		 -

    Reporting group title
    Room temperature
    Reporting group description
    		 -

    Reporting group values
    		 Body temperature Room temperature Total
    Number of subjects
    		 21 21 21
    Age categorical
    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)
    		 21 21 21
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 7 7
        Male
    		 14 14 14

    End points

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    End points reporting groups
    Reporting group title
    Body temperature
    Reporting group description
    		 -

    Reporting group title
    Room temperature
    Reporting group description
    		 -

    Primary: Change in cardiac index over 15 minutes

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    End point title
    		 Change in cardiac index over 15 minutes
    End point description
    End point type
    Primary
    End point timeframe
    15 minutes
    End point values
    		 Body temperature Room temperature
    Number of subjects analysed
    20 [1]
    20 [2]
    Units: L/min/m2
        median (confidence interval 95%)
    0.09 (0.06 to 0.11)
    0.03 (0.01 to 0.06)
    Notes
    [1] - Data was not retrieved from one study session from one subject, and could be used for analysis
    [2] - Data was not retrieved from one study session from one subject, and could be used for analysis
    Statistical analysis title
    		 RMANOVA
    Comparison groups
    Body temperature v Room temperature
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.001
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The 2 study sessions and their monitoring periods.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 All test subjects

    Serious adverse events
    		 All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 21 (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: Not having any adverse advents is not surprising considering we are using a very safe medication (just an intravenous fluid) in a small population of young healthy volunteers. They were all monitored for the known issuess with this medication and none were found during this trial

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Feb 2017
    An amendment was made almost immediatly upon trial start, due to errors with documentation and versions of the study protocol. It was incorrectly stated in one version of the initial application to the national MPA that the room temperature fluid would be at 25 degrees celsius rather than 22. This was incorrect and a request to amend this was submitted and granted by the MPA. No change was made in the actual trial managedment, all fluid given in the room temperature arm was at 22 degrees and no subjects were exposed to any risk due to this

    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/30482135
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