Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Effect of norepinephrine infusion on hepatic blood flow during goal-directed hemodynamic therapy.

    Summary
    EudraCT number
    2018-004139-66
    Trial protocol
    BE  
    Global end of trial date
    23 Oct 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Jul 2024
    First version publication date
    06 Jul 2024
    Other versions
    Summary report(s)
    Final Study Report

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    AGO/2018/006
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UZ Gent
    Sponsor organisation address
    C. Heymanslaan 10, Gent, Belgium, 9000
    Public contact
    Hiruz CTU, Ghent University Hospital, +32 93320530, hiruz.ctu@uzgent.be
    Scientific contact
    Hiruz CTU, Ghent University Hospital, 093320530 93320530, 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
    07 Aug 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of norepinephrine infusion (NOR) on hepatic blood flow and hepatic vascular pressures during goal-directed hemodynamic therapy.
    Protection of trial subjects
    See attachement
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 May 2019
    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: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    10
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    See attachement

    Pre-assignment
    Screening details
    See Attachement

    Period 1
    Period 1 title
    Overal Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Not relevant

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group S
    Arm description
    See attachement
    Arm type
    group S

    Investigational medicinal product name
    Norepinephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    See attachement

    Arm title
    Group NS
    Arm description
    See attachement
    Arm type
    Group NS

    Investigational medicinal product name
    Norepinephrine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    See attachement

    Number of subjects in period 1
    Group S Group NS
    Started
    20
    8
    Completed
    20
    8

    Baseline characteristics

    Close Top of page

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Group S
    Reporting group description
    See attachement

    Reporting group title
    Group NS
    Reporting group description
    See attachement

    Primary: Primary

    Close Top of page
    End point title
    Primary [1]
    End point description
    End point type
    Primary
    End point timeframe
    See attachement
    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: See attachement
    End point values
    Group S Group NS
    Number of subjects analysed
    20
    8
    Units: Subjects
    20
    8
    No statistical analyses for this end point

    Secondary: Secondary

    Close Top of page
    End point title
    Secondary
    End point description
    End point type
    Secondary
    End point timeframe
    See attachement
    End point values
    Group S Group NS
    Number of subjects analysed
    20
    8
    Units: Subjects
    20
    8
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    During the study
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    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: See attachement

    More information

    Close Top of page

    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
    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.

    European Medicines Agency © 1995-Wed May 07 06:16:21 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA