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    Clinical Trial Results:
    Individualised perioperative blood pressure and fluid therapy in oesophagectomy - Study protocol for a prospective randomised controlled trial

    Summary
    EudraCT number
    		 2021-002816-30
    Trial protocol
    		 DK  
    Global end of trial date
    06 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jun 2026
    First version publication date
    04 Jun 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    01072021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aarhus University Hospital
    Sponsor organisation address
    Palle Juul-Jensens Blvd. 99, Aarhus, Denmark, 8200
    Public contact
    Department of Anaesthesiology, Department of Anaesthesiology, Aarhus University Hospital, peter.juhl-olsen@clin.au.dk
    Scientific contact
    Department of Anaesthesiology, Department of Anaesthesiology, Aarhus University Hospital, peter.juhl-olsen@clin.au.dk
    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
    06 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Oct 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Version 2.1 Date: 03.06.22 To investigate the impact of goal directed fluid therapy (GDT) vs. standard fluid/vasoactive therapy in the perioperative phase of oesophagectomy on comprehensive complication index at 30 days
    Protection of trial subjects
    Treated in routine care or with protocolised haemodynamic treatment
    Background therapy
    		 Standard surgical and medical care for oesophagectomy at Aarhus University Hospital
    Evidence for comparator
    		 See local guideline (edok.dk)
    Actual start date of recruitment
    01 Nov 2021
    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
    Denmark: 102
    Worldwide total number of subjects
    102
    EEA total number of subjects
    102
    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)
    47
    From 65 to 84 years
    53
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment from one center

    Pre-assignment
    Screening details
    		 We screened patients scheduled for oesophagectomy at Aarhus University Hospital

    Period 1
    Period 1 title
    Full trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Blinding integrity was assessed by having patients and outcome assessors guess study group allocation after the follow-up period

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 eGDT
    Arm description
    		 Protocolised haemodynamic treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    norepinephrine
    Investigational medicinal product code
    C01CA03
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Infusion
    Dosage and administration details
    According to study protokol

    Arm title
    		 Standard treatment
    Arm description
    		 Standard haemodynamic treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Norepinephrine
    Investigational medicinal product code
    C01CA03
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Infusion
    Dosage and administration details
    According to pre specified protokol

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: This is appropriate for this trial design
    Number of subjects in period 1
    		eGDT Standard treatment
    Started
    50
    52
    Completed
    49
    51
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    -
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Full trial
    Reporting group description
    		 -

    Reporting group values
    		 Full trial Total
    Number of subjects
    		 102 102
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 47 47
        From 65-84 years
    		 53 53
        85 years and over
    		 2 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 68 ( 9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 27 27
        Male
    		 75 75
    Subject analysis sets

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients that underwent the intervention

    Subject analysis sets values
    		 Intention-to-treat
    Number of subjects
    100
    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)
    47
        From 65-84 years
    53
        85 years and over
    2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    68 ( 9 )
    Gender categorical
    Units: Subjects
        Female
    25
        Male
    75

    End points

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    End points reporting groups
    Reporting group title
    eGDT
    Reporting group description
    		 Protocolised haemodynamic treatment

    Reporting group title
    Standard treatment
    Reporting group description
    		 Standard haemodynamic treatment

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients that underwent the intervention

    Primary: Comprehensive Complication Index on postoparative day 30

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    End point title
    		 Comprehensive Complication Index on postoparative day 30
    End point description
    End point type
    Primary
    End point timeframe
    postoparative day 30
    End point values
    		 eGDT Standard treatment
    Number of subjects analysed
    49
    51
    Units: 1-100
    39
    39
    Statistical analysis title
    		 Primary Endpoint statistics
    Statistical analysis description
    The between-group differences in CCI 30 days after surgery (primary endpoint) and 90 days after surgery were analysed using linear regression with study group allocation and open/not open procedure as independent variables.
    Comparison groups
    eGDT v Standard treatment
    Number of subjects included in analysis
    100
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.95
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.6
         upper limit
    		 8.1

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    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: These were reported directly to the Danish Medicines Agency

    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.
    The sample size was based on an anticipated 35% relative reduction in CCI.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/41452340
    http://www.ncbi.nlm.nih.gov/pubmed/37125828
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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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