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    Clinical Trial Results:
    Comparison of the efficacy of ephedrine versus norepinephrine in the treatment of hypotension occurring after induction of general anesthesia in patients with chronic renal failure: randomized double-blind pilot study

    Summary
    EudraCT number
    		 2022-002892-12
    Trial protocol
    		 BE  
    Global end of trial date
    27 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jul 2024
    First version publication date
    21 Jul 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHUB-VASO-IRC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU Brugmann
    Sponsor organisation address
    4 Place Arthur Van Gehuchten , Brussels, Belgium, 1020
    Public contact
    Anesthesiology Department, CHU Brugmann, 32 24775676, zakaria.cheffi@chu-brugmann.be
    Scientific contact
    Anesthesiology Department, CHU Brugmann, 32 24775676, zakaria.cheffi@chu-brugmann.be
    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
    27 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jul 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main aim of this study is to compare the efficacy of ephedrine versus norepinephrine in the treatment of hypotension occurring after induction of general anesthesia in patients with chronic renal failure during elective surgery.
    Protection of trial subjects
    The risk to which the patient is exposed is the risk linked to general anesthesia. This risk is in practice controlled by the means implemented daily for patients undergoing general anesthesia within the hospital.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Sep 2022
    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: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    11
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This is a monocentric study held within the CHU Brugmann Hospital. Recruitment started on 13 september 2022. The study did not reach its recruitment goal (early termination on 27 July 2023).

    Pre-assignment
    Screening details
    		 The study was offered to all patients of the CHU Brugmann Hospital with chronic renal failure either during the anesthesia consultation or during the pre-anesthetic visit in the room.

    Period 1
    Period 1 title
    Entire trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Noradrenalin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Noradrenaline tartate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    The patient receives a bolus of 2ml of noradrenalin 3µg/ml every 3 minutes if he/she is hypotensive, until the blood pressure is above the set thresholds (mean arterial pressure (MAP) >65 mmHg).

    Arm title
    		 Ephedrin
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ephedrine hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    The patient receives a bolus of 2 ml of ephedrine 3 mg/ml every 3 minutes if he/she is hypotensive, until the blood pressure is above the set thresholds (mean arterial pressure (MAP) >65 mmHg).

    Number of subjects in period 1
    		Noradrenalin Ephedrin
    Started
    12
    12
    Completed
    8
    9
    Not completed
    4
    3
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    2
    -
         Not randomized
    -
    1
         Lost to follow-up
    -
    1
         Protocol deviation
    1
    1

    Baseline characteristics

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

    Reporting group title
    Ephedrin
    Reporting group description
    		 -

    Reporting group values
    		 Noradrenalin Ephedrin Total
    Number of subjects
    		 12 12 24
    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)
    		 5 6 11
        From 65-84 years
    		 7 6 13
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 4 2 6
        Male
    		 8 10 18

    End points

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

    Reporting group title
    Ephedrin
    Reporting group description
    		 -

    Primary: Amount of boluses to maintain a mean arterial pressure >65mmHg

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    End point title
    		 Amount of boluses to maintain a mean arterial pressure >65mmHg [1]
    End point description
    End point type
    Primary
    End point timeframe
    From the start of the surgical procedure until the first parameter measurement in the post-intervention monitoring room.
    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: The trial ended prematurely without reaching its recruitment goal. It makes no sense to perform statistics on such a small patient sample.
    End point values
    		 Noradrenalin Ephedrin
    Number of subjects analysed
    8
    9
    Units: N/A
        median (inter-quartile range (Q1-Q3))
    0.5 (0 to 4.25)
    0 (0 to 3)
    No statistical analyses for this end point

    Primary: Mean arterial pressure (MAP) during intervention

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    End point title
    		 Mean arterial pressure (MAP) during intervention [2]
    End point description
    End point type
    Primary
    End point timeframe
    From the start of the surgical procedure until the first parameter measurement in the post-intervention monitoring room.
    Notes
    [2] - 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: The trial ended prematurely without reaching its recruitment goal. It makes no sense to perform statistics on such a small patient sample.
    End point values
    		 Noradrenalin Ephedrin
    Number of subjects analysed
    8
    9
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    88 (79.75 to 99.25)
    87 (73 to 92)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Entire trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Noradrenalin
    Reporting group description
    		 -

    Reporting group title
    Ephedrin
    Reporting group description
    		 -

    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: The study team confirmed no non-serious AE occurred.
    Serious adverse events
    		 Noradrenalin Ephedrin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Septic shock
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Noradrenalin Ephedrin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 9 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Nov 2022
    - Modifications in inclusion/exclusion criteria (age extended to 75 years, BMI limit 35) - Modifications in the 'standard of care' procedure for anesthesia (details on the hypnotic and curarizing agents) - Change in co-investigators

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    27 Jul 2023
    Premature end of trial
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Methodological issue: in order to have significant results, 360 patients (180 per group) would be needed (instead of the 60 foreseen by the protocol). This is not feasible in our hospital setting.
    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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