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    Clinical Trial Results:
    Effect of hypertonic saline solute compared to ringer lactate on right ventricular function after cardiac surgery

    Summary
    EudraCT number
    		 2015-004485-28
    Trial protocol
    		 FR  
    Global end of trial date
    24 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 May 2022
    First version publication date
    25 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    38RC15.214
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Grenoble University Hospital
    Sponsor organisation address
    CS 10217 , Grenoble, France, 38043
    Public contact
    Dr Michel DURAND, Centre Hospitalier Universitaire, 33 04 76 76 55 10 , MDurand@chu-grenoble.fr
    Scientific contact
    Dr Michel DURAND, Centre Hospitalier Universitaire, 33 04 76 76 55 10 , MDurand@chu-grenoble.fr
    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
    24 Aug 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was right ventricular function improvement after hypertonic saline solution infusion compared to an isotonic solution
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements including relative provisions to biomedical research of “Code de la santé publique” . The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. The protocol has been authorized by the “Comité de Protection des personnes Sud Est” and the “Agence nationale de sécurité du medicament”.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 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
    France: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    13
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients undergoing cardicac surgery (valvular replacement, coronary bypass surgery or ascending aorta surgery) in the CHU de Grenoble. Patients had to be in sinus rhythm, and have an indication for swan Ganz catheter.

    Pre-assignment
    Screening details
    		 The recruitment will be done in patients who will undergo cardiac surgery for coronary bypass or valvulopathy in the cardiac surgery department of the University Hospital of Grenoble.

    Pre-assignment period milestones
    Number of subjects started
    		 30
    Number of subjects completed
    		 30

    Period 1
    Period 1 title
    hypertonic saline sol 7.5/Ringer lactate (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
    		 Hypertonic Saline Solution
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hypertonic Saline Solution (HSS) 7.5%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mL/kg

    Arm title
    		 Ringer Lactate
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ringer Lactate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mL/kg

    Number of subjects in period 1
    		Hypertonic Saline Solution Ringer Lactate
    Started
    15
    15
    Completed
    15
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Hypertonic Saline Solution
    Reporting group description
    		 -

    Reporting group title
    Ringer Lactate
    Reporting group description
    		 -

    Reporting group values
    		 Hypertonic Saline Solution Ringer Lactate Total
    Number of subjects
    		 15 15 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 7 6 13
        From 65-84 years
    		 8 9 17
    Gender categorical
    Units: Subjects
        Female
    		 12 12 24
        Male
    		 3 3 6

    End points

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    End points reporting groups
    Reporting group title
    Hypertonic Saline Solution
    Reporting group description
    		 -

    Reporting group title
    Ringer Lactate
    Reporting group description
    		 -

    Primary: Evolution of right ventricular ejection fraction (RVEF) 30 minutes after volume expansion of a filling solution in the two arm groups.

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    End point title
    		 Evolution of right ventricular ejection fraction (RVEF) 30 minutes after volume expansion of a filling solution in the two arm groups.
    End point description
    End point type
    Primary
    End point timeframe
    30 minutes after volume expansion of a filling solution in the two arm groups.
    End point values
    		 Hypertonic Saline Solution Ringer Lactate
    Number of subjects analysed
    15
    15
    Units: percentage
        median (inter-quartile range (Q1-Q3))
    35 (26 to 41)
    28 (23 to 33)
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    Primary analysis A Student's t test will be performed for the comparison of FEVD in the two groups. It will be replaced by the non-parametric Mann-Whitney test when the normality or homogeneity of variances has been rejected
    Comparison groups
    Hypertonic Saline Solution v Ringer Lactate
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03 [1]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - End point values: - Arm 1: 35 - Arm 2: 28

    Secondary: Explore improvement in left ventricular function (LVEF)

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    End point title
    		 Explore improvement in left ventricular function (LVEF)
    End point description
    End point type
    Secondary
    End point timeframe
    30, 60 minutes and 3, 6 and 18 hours after infusion
    End point values
    		 Hypertonic Saline Solution Ringer Lactate
    Number of subjects analysed
    15 [2]
    15 [3]
    Units: dp/DT / VS
        geometric mean (geometric coefficient of variation)
    24 ( 0.44 )
    24.5 ( 0.07 )
    Notes
    [2] - end point value: 24
    [3] - end point value: 24.5
    Statistical analysis title
    		 Explore improvement in left ventricular function
    Statistical analysis description
    Explore improvement in left ventricular function (LVEF)
    Comparison groups
    Hypertonic Saline Solution v Ringer Lactate
    Number of subjects included in analysis
    30
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.44 [4]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [4] - P-value: 0.44 / 0.07

    Secondary: Demonstrate improvement in microcirculation

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    End point title
    		 Demonstrate improvement in microcirculation
    End point description
    Countable units : continuous cardiac output, venous oxygen saturation, and mean arterial pressure, in the hours following infusion at 30, 60 minutes and 3, 6, and 18 hours post-infusion.
    End point type
    Secondary
    End point timeframe
    30, 60 minutes and 3, 6, and 18 hours post-infusion.
    End point values
    		 Hypertonic Saline Solution Ringer Lactate
    Number of subjects analysed
    15 [5]
    15 [6]
    Units: continuous cardiac output
    66
    68
    Notes
    [5] - end point values: 1.7 / 67.5 / 66
    [6] - 1.6 / 62.4 / 68.5
    Statistical analysis title
    		 Secondary analysis
    Comparison groups
    Hypertonic Saline Solution v Ringer Lactate
    Number of subjects included in analysis
    30
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.13
    Method
    		 ANOVA
    Confidence interval
    Notes
    [7] - End point values arm 2: 1.6 / 62.4 / 68.5

    Secondary: Explore volumetric efficiency

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    End point title
    		 Explore volumetric efficiency
    End point description
    Systolic and diastolic right ventricular volumes measured by Swan Ganz, central venous pressure in the hour before filling and at 30, 60 minutes and 3, 6 and 18 hours after filling.
    End point type
    Secondary
    End point timeframe
    1, 6, 18 hours after infusion
    End point values
    		 Hypertonic Saline Solution Ringer Lactate
    Number of subjects analysed
    15
    15
    Units: ventricular vol, central venous pressure
    109
    89
    Statistical analysis title
    		 secondary analysis
    Comparison groups
    Hypertonic Saline Solution v Ringer Lactate
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.3 [8]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [8] - 0.3 / 0.8 / 0.6

    Secondary: explore tolerance to hypertonic saline

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    End point title
    		 explore tolerance to hypertonic saline
    End point description
    Countable units : measurement of natraemia, and lactatemia at 1, 6, 18 hours after infusion
    End point type
    Secondary
    End point timeframe
    1, 6, 18 hours after infusion
    End point values
    		 Hypertonic Saline Solution Ringer Lactate
    Number of subjects analysed
    15
    15
    Units: natraemia and lactatemia
    137
    138
    Statistical analysis title
    		 secondary analysis
    Comparison groups
    Ringer Lactate v Hypertonic Saline Solution
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    throughout the study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    ventricular tachycardia
    Reporting group description
    		 -

    Serious adverse events
    		 ventricular tachycardia
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (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
    		 ventricular tachycardia
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 30 (6.67%)
    Cardiac disorders
    Ventricular tachycardia
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    30

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Apr 2017
    Update of the BI and DME of sodium chloride APHP 7.5% following a batch change.
    19 May 2017
    Extension of the inclusion period by 1 year until June 2018 Update of the vigilance part

    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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