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    Clinical Trial Results:
    Determination of the optimal dose of ephedrine to treat hypotension during surgery of newborn to six months infant

    Summary
    EudraCT number
    		 2014-004190-16
    Trial protocol
    		 FR  
    Global end of trial date
    05 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2025
    First version publication date
    13 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    69HCL14-0248
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02384876
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hospices Civils de Lyon
    Sponsor organisation address
    3 Quai des Célestins, Lyon, France, 69002
    Public contact
    Alexandre Pachot, Hospices Civils de Lyon, 33 0472406840, drci_promo@chu-lyon.fr
    Scientific contact
    De Queiroz-Siqueira, Hospices Civils de Lyon, mathilde.de-queiroz-siqueira@chu-lyon.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
    21 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the optimal dose of ephedrine (in mg/kg) to be used as a first-line, in single administration, in intraoperative arterial hypotension of newborns and infants up to six months of age
    Protection of trial subjects
    The trial was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial. A safety monitoring committee was established before the start of the trial. Recommendations were given on the continuation of the study between each cohort and at each occurrence of a serious adverse event.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2015
    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
    France: 119
    Worldwide total number of subjects
    119
    EEA total number of subjects
    119
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    8
    Infants and toddlers (28 days-23 months)
    111
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients meeting the eligibility criteria and admitted to the pediatric anesthesia departments headed by Prof. Chassard (Hôpital Femme Mère Enfant, Hospices Civils de Lyon), Prof. Bazin (Hôpital Estaing, CHU Clermont Ferrand) and Prof. Moliex (Hôpital Nord, CHU Saint-Etienne) were proposed participation in the trial.

    Pre-assignment
    Screening details
    		 All patients meeting the eligibility criteria and admitted to the pediatric anesthesia departments headed by Prof. Chassard (Hôpital Femme Mère Enfant, Hospices Civils de Lyon), Prof. Bazin (Hôpital Estaing, CHU Clermont Ferrand) and Prof. Moliex (Hôpital Nord, CHU Saint-Etienne) were proposed participation in the trial.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ephedrine 0.1 mg/kg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ephedrine 30mg/100mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    single administration in case of hypotension at the anesthesia induction.

    Arm title
    		 Ephedrine 0.6 mg/kg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ephedrine 30mg/100mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    single administration in case of hypotension at the anesthesia induction.

    Arm title
    		 Ephedrine 0.8 mg/kg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ephedrine 30mg/100mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    single administration in case of hypotension at the anesthesia induction.

    Arm title
    		 Ephedrine 1 mg/kg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ephedrine 30mg/100mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    single administration in case of hypotension at the anesthesia induction.

    Arm title
    		 Ephedrine 1.2 mg/kg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ephedrine 30mg/100mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    single administration in case of hypotension at the anesthesia induction.

    Arm title
    		 Ephedrine 1.4 mg/kg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ephedrine 30mg/100mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    single administration in case of hypotension at the anesthesia induction.

    Number of subjects in period 1
    		Ephedrine 0.1 mg/kg Ephedrine 0.6 mg/kg Ephedrine 0.8 mg/kg Ephedrine 1 mg/kg Ephedrine 1.2 mg/kg Ephedrine 1.4 mg/kg
    Started
    24
    24
    21
    17
    16
    17
    Completed
    24
    24
    21
    17
    16
    17

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ephedrine 0.1 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 0.6 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 0.8 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 1 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 1.2 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 1.4 mg/kg
    Reporting group description
    		 -

    Reporting group values
    		 Ephedrine 0.1 mg/kg Ephedrine 0.6 mg/kg Ephedrine 0.8 mg/kg Ephedrine 1 mg/kg Ephedrine 1.2 mg/kg Ephedrine 1.4 mg/kg Total
    Number of subjects
    		 24 24 21 17 16 17 119
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 1 1 2 1 2 1 8
        Infants and toddlers (28 days-23 months)
    		 23 23 19 16 14 16 111
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 2 7 3 5 4 30
        Male
    		 15 22 14 14 11 13 89
    Subject analysis sets

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all patients who were randomized and who received the treatment

    Subject analysis sets values
    		 Per Protocol Set
    Number of subjects
    119
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    8
        Infants and toddlers (28 days-23 months)
    111
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    30
        Male
    89

    End points

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    End points reporting groups
    Reporting group title
    Ephedrine 0.1 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 0.6 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 0.8 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 1 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 1.2 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 1.4 mg/kg
    Reporting group description
    		 -

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    all patients who were randomized and who received the treatment

    Primary: Percentage of success

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    End point title
    		 Percentage of success
    End point description
    The primary outcome was defined as a MAP greater than 80% of the baseline MAP within 10 minutes post ephedrine administration. Another infusion of ephedrine or the administration of dopamine or adrenaline, or a vascular filling, within 10 minutes after the initial dose of ephedrine were considered as a failure. Baseline MAP was the mean of two MAP recorded before anaesthetic induction
    End point type
    Primary
    End point timeframe
    10 minutes
    End point values
    		 Ephedrine 0.1 mg/kg Ephedrine 0.6 mg/kg Ephedrine 0.8 mg/kg Ephedrine 1 mg/kg Ephedrine 1.2 mg/kg Ephedrine 1.4 mg/kg Per Protocol Set
    Number of subjects analysed
    24
    24
    21
    17
    16
    17
    119
    Units: Events
    3
    7
    8
    8
    9
    7
    42
    Statistical analysis title
    		 Logistic regression model, adjusted on the cohort
    Comparison groups
    Ephedrine 0.6 mg/kg v Ephedrine 0.1 mg/kg
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 NA
    Point estimate
    13.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.7
         upper limit
    		 35.4
    Notes
    [1] - precision of the estimate
    Statistical analysis title
    		 Logistic regression model, adjusted on the cohort
    Comparison groups
    Ephedrine 0.8 mg/kg v Ephedrine 0.1 mg/kg
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 NA
    Point estimate
    32.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.4
         upper limit
    		 59.1
    Notes
    [2] - precision of the estimate
    Statistical analysis title
    		 Logistic regression model, adjusted on the cohort
    Comparison groups
    Ephedrine 1 mg/kg v Ephedrine 0.1 mg/kg
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    Parameter type
    		 NA
    Point estimate
    37.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.9
         upper limit
    		 67.2
    Notes
    [3] - precision of the estimate
    Statistical analysis title
    		 Logistic regression model, adjusted on the cohort
    Comparison groups
    Ephedrine 1.2 mg/kg v Ephedrine 0.1 mg/kg
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    Parameter type
    		 NA
    Point estimate
    56.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.7
         upper limit
    		 80.2
    Notes
    [4] - precision of the estimate
    Statistical analysis title
    		 Logistic regression model, adjusted on the cohort
    Comparison groups
    Ephedrine 1.4 mg/kg v Ephedrine 0.1 mg/kg
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    Parameter type
    		 NA
    Point estimate
    31.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 63.9
    Notes
    [5] - precision of the estimate

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Continuous AE reporting from randomization (day of general anesthesia) to end of participation (hospitalization time ; three days max).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    xx
    Reporting groups
    Reporting group title
    Ephedrine 0.1 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 0.6 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 0.8 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 1 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 1.2 mg/kg
    Reporting group description
    		 -

    Reporting group title
    Ephedrine 1.4 mg/kg
    Reporting group description
    		 -

    Serious adverse events
    		 Ephedrine 0.1 mg/kg Ephedrine 0.6 mg/kg Ephedrine 0.8 mg/kg Ephedrine 1 mg/kg Ephedrine 1.2 mg/kg Ephedrine 1.4 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    1 / 21 (4.76%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Pseudomeningocele
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 21 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 21 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Absence seizure
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 21 (4.76%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 21 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Escherichia coli infection
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 21 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ephedrine 0.1 mg/kg Ephedrine 0.6 mg/kg Ephedrine 0.8 mg/kg Ephedrine 1 mg/kg Ephedrine 1.2 mg/kg Ephedrine 1.4 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    0 / 21 (0.00%)
    3 / 17 (17.65%)
    3 / 16 (18.75%)
    0 / 17 (0.00%)
    Injury, poisoning and procedural complications
    Administration error at the time of ephedrine injection
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 21 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Digestive pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 21 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    DIARRHEA
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 21 (0.00%)
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 21 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Renal and urinary disorders
    Urinary globe
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 21 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    HEMATURIA
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 21 (0.00%)
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    HYPOVOLEMIA
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 21 (0.00%)
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2015
    change of coordinating investigator and eligibility criteria
    30 May 2017
    change of coordinating investigator+ extension of the recruitement period
    21 May 2019
    extension of the recruitment period and implementation of GPRD
    09 Jun 2020
    extension of the recruitment period

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    16 Mar 2020
    COVID period
    19 Jun 2020

    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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