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    Clinical Trial Results:
    Effect of strategy for blood pressure control on cerebral oxygen balance during aortic coarctation repair: a randomized study

    Summary
    EudraCT number
    		 2007-002640-19
    Trial protocol
    		 BE  
    Global end of trial date
    15 Mar 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Nov 2021
    First version publication date
    07 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2007/003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00535808
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    C. Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    HIRUZ CTU, Ghent University Hospital, 32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    HIRUZ CTU, Ghent University Hospital, 32 93320500, hiruz.ctu@uzgent.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
    01 Jun 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Mar 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    investigation of the effect of different blood pressure controlling agents on the cerebral oxygen balance between both brain hemispheres during aortic coarctation repair by using near-infrared technology
    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
    01 Oct 2007
    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: 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)
    15
    Infants and toddlers (28 days-23 months)
    15
    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
    		 Last patient last visit was on 15MAR2011

    Pre-assignment
    Screening details
    		 All neonates and infants, aged 0 – 18 year, with aortic coarctation requiring surgical correction without the additional use of cardiopulmonary bypass

    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
    		 Nitroprusside
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nitroprusside
    Investigational medicinal product code
    Other name
    Nitropress
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg/2 ml vial for intravenous use, 0.1 – 2 µg/kg/min. The solution must be further diluted in sterile 5% dextrose injection before infusion

    Arm title
    		 Nitroglycerine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nitroglycerine
    Investigational medicinal product code
    Other name
    Solinitrina
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    50 mg/10 ml ampoule for intravenous use, 0.1 – 2 µg/kg/min

    Arm title
    		 Sevoflurane
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sevoflurane
    Investigational medicinal product code
    Other name
    Sevorane
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    250 ml bottle, volatile anesthetic, 0.5 – 5 %

    Number of subjects in period 1
    		Nitroprusside Nitroglycerine Sevoflurane
    Started
    10
    10
    10
    Completed
    10
    10
    10

    Baseline characteristics

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

    Reporting group title
    Nitroglycerine
    Reporting group description
    		 -

    Reporting group title
    Sevoflurane
    Reporting group description
    		 -

    Reporting group values
    		 Nitroprusside Nitroglycerine Sevoflurane Total
    Number of subjects
    		 10 10 10 30
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Age of patients
    Units: days
        median (full range (min-max))
    		 20 (3 to 77) 90 (5 to 568) 12 (4 to 193) -
    Gender categorical
    Units: Subjects
        Female
    		 2 4 3 9
        Male
    		 8 6 7 21
    ASA physical status
    Units: Subjects
        II
    		 6 4 5 15
        III
    		 4 5 5 14
        status I
    		 0 1 0 1
    Weight
    Units: kg
        median (full range (min-max))
    		 3.6 (1.4 to 5.7) 5.1 (3.2 to 11.3) 3.3 (2.0 to 8.6) -
    BSA
    Units: m2
        median (full range (min-max))
    		 0.22 (0.12 to 0.28) 0.27 (0.2 to 0.49) 0.21 (0.15 to 0.39) -

    End points

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

    Reporting group title
    Nitroglycerine
    Reporting group description
    		 -

    Reporting group title
    Sevoflurane
    Reporting group description
    		 -

    Primary: Max change in renal oxygen saturation

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    End point title
    		 Max change in renal oxygen saturation
    End point description
    End point type
    Primary
    End point timeframe
    measured during the trial
    End point values
    		 Nitroprusside Nitroglycerine Sevoflurane
    Number of subjects analysed
    10
    10
    10
    Units: percentage
        arithmetic mean (standard deviation)
    -59 ( 13 )
    -33 ( 22 )
    -43 ( 19 )
    Statistical analysis title
    		 Mean difference maximal relative change
    Comparison groups
    Nitroglycerine v Sevoflurane v Nitroprusside
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.04
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: Max change in muscle oxygen saturation

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    End point title
    		 Max change in muscle oxygen saturation
    End point description
    End point type
    Primary
    End point timeframe
    overall trial
    End point values
    		 Nitroprusside Nitroglycerine Sevoflurane
    Number of subjects analysed
    10
    10
    10
    Units: percentage
        arithmetic mean (standard deviation)
    -64 ( 17 )
    -34 ( 25 )
    -55 ( 19 )
    Statistical analysis title
    		 Max change in muscle oxygen saturation
    Comparison groups
    Nitroglycerine v Nitroprusside v Sevoflurane
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.014
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: Decay rate renal oxygen saturation

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    End point title
    		 Decay rate renal oxygen saturation
    End point description
    End point type
    Primary
    End point timeframe
    overall trial
    End point values
    		 Nitroprusside Nitroglycerine Sevoflurane
    Number of subjects analysed
    10
    10
    10
    Units: percentage per minute
        arithmetic mean (standard deviation)
    -7.7 ( 2.7 )
    -3.9 ( 3.0 )
    -5.6 ( 3.1 )
    Statistical analysis title
    		 Decay rate renal oxygen saturation
    Comparison groups
    Nitroprusside v Nitroglycerine v Sevoflurane
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.034
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: Decay rate muscle oxygen saturation

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    End point title
    		 Decay rate muscle oxygen saturation
    End point description
    End point type
    Primary
    End point timeframe
    overall trial
    End point values
    		 Nitroprusside Nitroglycerine Sevoflurane
    Number of subjects analysed
    10
    10
    10
    Units: percentage per minute
        arithmetic mean (standard deviation)
    -9.3 ( 3.7 )
    -3.9 ( 2.7 )
    -6.2 ( 2.4 )
    Statistical analysis title
    		 Decay rate SmO2
    Comparison groups
    Nitroprusside v Nitroglycerine v Sevoflurane
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.003
    Method
    		 Kruskal-wallis
    Confidence interval

    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
    Frequency threshold for reporting non-serious adverse events: 5%
    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 adverse events have been recorded during the study

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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