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    Clinical Trial Results:
    Crystalloids or colloids for goal-directed fluid therapy with closed-loop assistance in major surgery?

    Summary
    EudraCT number
    		 2014-005337-31
    Trial protocol
    		 BE  
    Global end of trial date
    21 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2021
    First version publication date
    29 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHUB-fluides
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02312999
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CHU Brugmann
    Sponsor organisation address
    4 Place A. Van Gehuchten , Brussels, Belgium, 1020
    Public contact
    Service of Anesthesiology, CHU Brugmann, 32 024772330, Philippe.Vanderlinden@chu-brugmann.be
    Scientific contact
    Service of Anesthesiology, CHU Brugmann, 32 024772330 , Philippe.Vanderlinden@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
    21 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jul 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will examine whether there is a significant difference in postoperative outcomes between GDFT using a colloid solution versus a crystalloid solution.
    Protection of trial subjects
    This clinical trial compares two intravenous solutions, with a marketing authorization, that are given according to the standard of care. Therefore, no additonal measures were taken apart from a monitoring of side effects, that were treated according to protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2015
    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: 160
    Worldwide total number of subjects
    160
    EEA total number of subjects
    160
    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)
    81
    From 65 to 84 years
    79
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This is a monocentric trial in Belgium. Recruitment occured between April 2015 and November 2016.

    Pre-assignment
    Screening details
    		 Screening occured during the pre-anesthesia consultation. 198 patients were assessed for eligibility. 38 were excluded for the following reasons (4: atrial fibrillation, 7: preoperative renal failure, 1: aortic insufficiency, 7: decline to participate, 1: dementia, 4: logistic reasons, 1: jeovah witness, 1: minor patient, 12: hepatic disfunction).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    The randomization of the study (1:1) was created by the hospital pharmacist in blocks of 10. The morning of the surgey, blinded fluid solutions (visually identical plastic bags of 500ml) were delivered to the anesthesiologist in charge of the patient. The preparation, storage and dispensing of the study fluids was done independently by the hospital pharmacy of each institution. Study fluids were only identified by the assigned patient number.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Plasmalyte
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Plasmalyte
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 litres per day by intravenous use

    Arm title
    		 Volulyte
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Volulyte
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    33 mililiters/kg in total, intravenous use.

    Number of subjects in period 1
    		Plasmalyte Volulyte
    Started
    80
    80
    Completed
    80
    80

    Baseline characteristics

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

    Reporting group title
    Volulyte
    Reporting group description
    		 -

    Reporting group values
    		 Plasmalyte Volulyte Total
    Number of subjects
    		 80 80 160
    Age categorical
    Age
    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)
    		 42 39 81
        From 65-84 years
    		 36 39 75
        85 years and over
    		 2 2 4
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 62 (48 to 70) 65 (53 to 73) -
    Gender categorical
    Units: Subjects
        Female
    		 29 35 64
        Male
    		 51 45 96

    End points

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

    Reporting group title
    Volulyte
    Reporting group description
    		 -

    Primary: POMS score

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    End point title
    		 POMS score
    End point description
    Difference between the 2 groups in postoperative morbidity identified with the post-operative morbidity survey (POMS score) on postoperative day 2.
    End point type
    Primary
    End point timeframe
    Postoperative day 2
    End point values
    		 Plasmalyte Volulyte
    Number of subjects analysed
    80
    80
    Units: none
    3
    2
    Statistical analysis title
    		 Chi square
    Comparison groups
    Plasmalyte v Volulyte
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the entire clinical trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Clinical practice
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Plasmalyte
    Reporting group description
    		 -

    Reporting group title
    Volulyte
    Reporting group description
    		 -

    Serious adverse events
    		 Plasmalyte Volulyte
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 80 (22.50%)
    15 / 80 (18.75%)
         number of deaths (all causes)
    3
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Reoperation
         subjects affected / exposed
    6 / 80 (7.50%)
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Stroke
         subjects affected / exposed
    0 / 80 (0.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Sepsis
         subjects affected / exposed
    5 / 80 (6.25%)
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bleeding requiring a redo surgery
         subjects affected / exposed
    4 / 80 (5.00%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Anastomotic leak
         subjects affected / exposed
    4 / 80 (5.00%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Peritonitis
         subjects affected / exposed
    4 / 80 (5.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    3 / 80 (3.75%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    5 / 80 (6.25%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 80 (3.75%)
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Wound dehiscence
         subjects affected / exposed
    4 / 80 (5.00%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal replacement therapy
         subjects affected / exposed
    1 / 80 (1.25%)
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    18 / 80 (22.50%)
    15 / 80 (18.75%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Plasmalyte Volulyte
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 80 (62.50%)
    35 / 80 (43.75%)
    Nervous system disorders
    Postoperative confusion
         subjects affected / exposed
    4 / 80 (5.00%)
    2 / 80 (2.50%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Paralytic ileus
         subjects affected / exposed
    11 / 80 (13.75%)
    7 / 80 (8.75%)
         occurrences all number
    1
    1
    Postoperative nausea and vomiting
         subjects affected / exposed
    26 / 80 (32.50%)
    22 / 80 (27.50%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    5 / 80 (6.25%)
    5 / 80 (6.25%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Need for loop diuretics
         subjects affected / exposed
    9 / 80 (11.25%)
    4 / 80 (5.00%)
         occurrences all number
    1
    1
    Infections and infestations
    Superficial wound infection
         subjects affected / exposed
    5 / 80 (6.25%)
    4 / 80 (5.00%)
         occurrences all number
    1
    1
    Urinary and other infection
         subjects affected / exposed
    21 / 80 (26.25%)
    13 / 80 (16.25%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Nov 2015
    - Increase of total trial duration - Modification of the end of trial definition - Addition of a long-term monitoring (6 months and 1 year after surgery) of the effects of the two fluids on renal and hepatic function, occurrence of pruritus, and quality of life.
    24 Aug 2016
    Increase of total amount of patients recruited.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30418217
    http://www.ncbi.nlm.nih.gov/pubmed/29068831
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