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    Clinical Trial Results:
    Non-invasive bed-side measurement of systemic endothelial function in patients undergoing abdominal aortic aneurysm repair; modulation by ascorbic acid

    Summary
    EudraCT number
    		 2006-006887-44
    Trial protocol
    		 GB  
    Global end of trial date
    21 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Dec 2019
    First version publication date
    23 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RGHT000396
    Additional study identifiers
    ISRCTN number
    		 ISRCTN27369400
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Belfast Health & Social Care Trust (BHSCT)
    Sponsor organisation address
    King Edward Building, Royal Hospitals, Grosvenor Road, Belfast, United Kingdom, BT12 6BA
    Public contact
    Prof Daniel McAuley, Queen's University of Belfast, 02890 976385, d.f.mcauley@qub.ac.uk
    Scientific contact
    Prof Daniel McAuley, Queen's University of Belfast, 02890 976385, d.f.mcauley@qub.ac.uk
    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
    05 Aug 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Aug 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this pilot study is to investigate the acute effects of ascorbic acid supplementation on systemic and pulmonary endothelial function in the immediate post-operative period following AAA repair.
    Protection of trial subjects
    A DMEC was appointed which was independent of the study team. The DMEC functioned primarily as a check for safety, reviewing adverse events. The DMEC reported to the Sponsor via the principal investigator.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    20 Dec 2007
    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
    United Kingdom: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    4
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult patients admitted for elective open repair of AAA in the Royal Victoria Hospital, Belfast were screened for eligibility for participation in the study from December 2007 to July 2009.

    Pre-assignment
    Screening details
    		 Exclusion criteria were age less than 18 years old, a history of hyperoxaluria or glucose-6-phosphate dehydrogenase deficiency, prior antioxidant therapy, known allergy to ascorbic acid or to anaesthetic agents specified in anaesthetic protocol, participation in another intervention trial within 30 days or a lack of consent.

    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, Monitor, Assessor
    Blinding implementation details
    Patients received IV ascorbic acid 2g in 250 ml 0.9% saline or 250 ml 0.9% saline placebo. The randomization assignments were concealed in sealed, tamper-proof envelopes that were opened sequentially by an independent pharmacist. When an eligible subject was recruited, the pharmacist allocated the subject to the designated treatment group, maintaining blinding. Ascorbic acid and 0.9% saline were prepared by the independent pharmacist and had an identical appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ascorbic acid
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ascorbic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ascorbic acid 2g in 250 ml 0.9% saline over 15 minutes following induction of anaesthesia.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    0.9% saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    250ml 0.9% saline placebo over 15 minutes following induction of anaesthesia.

    Number of subjects in period 1
    		Ascorbic acid Placebo
    Started
    13
    18
    Completed
    13
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ascorbic acid
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Ascorbic acid Placebo Total
    Number of subjects
    		 13 18 31
    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)
    		 2 2 4
        From 65-84 years
    		 11 16 27
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 73.2 ( 5.9 ) 70.4 ( 7.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 1 3
        Male
    		 11 17 28
    IHD
    ischaemic heart disease
    Units: Subjects
        yes
    		 4 8 12
        no
    		 9 10 19
    atrial fibrillation
    Units: Subjects
        yes
    		 2 0 2
        no
    		 11 18 29
    hypertension
    Units: Subjects
        yes
    		 12 16 28
        no
    		 1 2 3
    cerebrovascular disease
    Units: Subjects
        yes
    		 1 1 2
        no
    		 12 17 29
    smoking
    Units: Subjects
        yes
    		 5 4 9
        no
    		 8 14 22
    hypercholesterolaemia
    Units: Subjects
        yes
    		 6 10 16
        no
    		 7 8 15
    diabetes
    Units: Subjects
        yes
    		 0 1 1
        no
    		 13 17 30
    statin
    Units: Subjects
        yes
    		 9 12 21
        no
    		 4 6 10
    ACE inhibitors
    Angiotensin Converting Enzyme inhibitors
    Units: Subjects
        yes
    		 3 5 8
        no
    		 10 13 23
    betablockers
    Units: Subjects
        yes
    		 6 7 13
        no
    		 7 11 18
    diuretics
    Units: Subjects
        yes
    		 3 2 5
        no
    		 10 16 26
    anticoagulants
    Units: Subjects
        yes
    		 5 5 10
        no
    		 8 13 21
    height
    Units: metres
        arithmetic mean (standard deviation)
    		 1.71 ( 0.05 ) 1.71 ( 0.09 ) -
    weight
    Units: kg
        arithmetic mean (standard deviation)
    		 78.2 ( 7.7 ) 77.1 ( 11.1 ) -
    body mass index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 26.8 ( 2.8 ) 26.4 ( 3.3 ) -
    respiratory rate
    Units: min-1
        median (inter-quartile range (Q1-Q3))
    		 12 (12 to 15) 14 (12 to 15) -
    temperature
    Units: degrees C
        arithmetic mean (standard deviation)
    		 36.8 ( 0.38 ) 36.6 ( 0.33 ) -
    heart rate
    Units: min-1
        arithmetic mean (standard deviation)
    		 60 ( 13.7 ) 63 ( 10.3 ) -
    peripheral systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 150.5 ( 29.6 ) 145.2 ( 24.9 ) -
    peripheral diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 76 ( 11.7 ) 77 ( 12.4 ) -
    Haemoglobin
    Units: gdl−1
        arithmetic mean (standard deviation)
    		 13.7 ( 1.1 ) 13.7 ( 1.2 ) -
    leucocyte count
    Units: x109ml−1
        arithmetic mean (standard deviation)
    		 7.3 ( 1.8 ) 7.3 ( 1.7 ) -
    platelet count
    Units: x109ml−1
        arithmetic mean (standard deviation)
    		 211 ( 64 ) 201 ( 54 ) -
    Urea
    Units: mmoll−1
        arithmetic mean (standard deviation)
    		 6.7 ( 1.8 ) 7.8 ( 2.1 ) -
    Creatinine
    Units: μmoll−1
        arithmetic mean (standard deviation)
    		 101 ( 30 ) 96 ( 31 ) -
    ischaemic time
    Units: minutes
        arithmetic mean (standard deviation)
    		 64.6 ( 17.6 ) 60.5 ( 16.9 ) -

    End points

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    End points reporting groups
    Reporting group title
    Ascorbic acid
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: vWF pre-operative

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    End point title
    		 vWF pre-operative
    End point description
    von Willebrand Factor
    End point type
    Primary
    End point timeframe
    pre-operative
    End point values
    		 Ascorbic acid Placebo
    Number of subjects analysed
    13
    18
    Units: % control
        arithmetic mean (standard deviation)
    139 ( 60 )
    141 ( 61 )
    Statistical analysis title
    		 vWF pre-operative comparison between groups
    Comparison groups
    Ascorbic acid v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.92
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: vWF post-operative

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    End point title
    		 vWF post-operative
    End point description
    von Willebrand Factor
    End point type
    Primary
    End point timeframe
    post-operative
    End point values
    		 Ascorbic acid Placebo
    Number of subjects analysed
    13
    18
    Units: % control
        arithmetic mean (standard deviation)
    169 ( 65 )
    158 ( 78 )
    Statistical analysis title
    		 vWF post-operative comparison between groups
    Comparison groups
    Ascorbic acid v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.68
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: EDV pre-operative

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    End point title
    		 EDV pre-operative
    End point description
    Endothelium-dependent vasodilatation
    End point type
    Secondary
    End point timeframe
    pre-operative
    End point values
    		 Ascorbic acid Placebo
    Number of subjects analysed
    13
    18
    Units: percentage
        median (inter-quartile range (Q1-Q3))
    3.0 (1.5 to 5.5)
    3.5 (1.8 to 5.3)
    Statistical analysis title
    		 EDV pre-operative comparison of groups
    Comparison groups
    Ascorbic acid v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.42
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: EDV post-operative

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    End point title
    		 EDV post-operative
    End point description
    End point type
    Secondary
    End point timeframe
    post-operative
    End point values
    		 Ascorbic acid Placebo
    Number of subjects analysed
    13
    18
    Units: percentage
        median (inter-quartile range (Q1-Q3))
    4.0 (2.0 to 6.0)
    6.0 (2.5 to 8.5)
    Statistical analysis title
    		 EDV post-operative comparison of groups
    Comparison groups
    Ascorbic acid v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.32
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Vd/Vt pre-operative

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    End point title
    		 Vd/Vt pre-operative
    End point description
    Pulmonary Deadspace Fraction
    End point type
    Secondary
    End point timeframe
    pre-operative
    End point values
    		 Ascorbic acid Placebo
    Number of subjects analysed
    13
    18
    Units: ratio
        arithmetic mean (standard deviation)
    0.54 ( 0.05 )
    0.56 ( 0.06 )
    Statistical analysis title
    		 Vd/Vt pre-operative comparison of groups
    Comparison groups
    Ascorbic acid v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.53
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Vd/Vt post-operative

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    End point title
    		 Vd/Vt post-operative
    End point description
    End point type
    Secondary
    End point timeframe
    post-operative
    End point values
    		 Ascorbic acid Placebo
    Number of subjects analysed
    13
    18
    Units: ratio
        arithmetic mean (standard deviation)
    0.54 ( 0.06 )
    0.56 ( 0.06 )
    Statistical analysis title
    		 Vd/Vt post-operative comparison of groups
    Comparison groups
    Ascorbic acid v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.74
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Serum hsCRP pre-operative

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    End point title
    		 Serum hsCRP pre-operative
    End point description
    C Reactive Protein
    End point type
    Secondary
    End point timeframe
    pre-operative
    End point values
    		 Ascorbic acid Placebo
    Number of subjects analysed
    13
    18
    Units: mgL−1
        median (inter-quartile range (Q1-Q3))
    1.83 (1.15 to 4.49)
    2.14 (0.97 to 5.75)
    Statistical analysis title
    		 Serum hsCRP pre-operative comparison of groups
    Comparison groups
    Ascorbic acid v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.95
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Serum hsCRP post-operative

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    End point title
    		 Serum hsCRP post-operative
    End point description
    C Reactive Protein
    End point type
    Secondary
    End point timeframe
    post-operative
    End point values
    		 Ascorbic acid Placebo
    Number of subjects analysed
    13
    18
    Units: mgL−1
        median (inter-quartile range (Q1-Q3))
    1.96 (1.13 to 4.23)
    2.85 (1.45 to 4.63)
    Statistical analysis title
    		 Serum hsCRP post-operative comparison of groups
    Comparison groups
    Ascorbic acid v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.27
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Arterial pH pre-operative

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    End point title
    		 Arterial pH pre-operative
    End point description
    End point type
    Secondary
    End point timeframe
    pre-operative
    End point values
    		 Ascorbic acid Placebo
    Number of subjects analysed
    13
    18
    Units: mmHg
        arithmetic mean (standard deviation)
    7.40 ( 0.05 )
    7.38 ( 0.04 )
    Statistical analysis title
    		 Arterial pH pre-operative comparison of groups
    Comparison groups
    Ascorbic acid v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.43
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Arterial pH post-operative

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    End point title
    		 Arterial pH post-operative
    End point description
    End point type
    Secondary
    End point timeframe
    post-operative
    End point values
    		 Ascorbic acid Placebo
    Number of subjects analysed
    13
    18
    Units: mmHg
        arithmetic mean (standard deviation)
    7.29 ( 0.06 )
    7.32 ( 0.08 )
    Statistical analysis title
    		 Arterial pH post-operative comparison of groups
    Comparison groups
    Ascorbic acid v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: PaO2:FiO2 ratio pre-operative

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    End point title
    		 PaO2:FiO2 ratio pre-operative
    End point description
    End point type
    Secondary
    End point timeframe
    pre-operative
    End point values
    		 Ascorbic acid Placebo
    Number of subjects analysed
    13
    18
    Units: kPa
        median (inter-quartile range (Q1-Q3))
    59.6 (46.5 to 97.7)
    59.6 (47.8 to 81.1)
    Statistical analysis title
    		 PaO2:FiO2 ratio pre-operative comparison of groups
    Comparison groups
    Ascorbic acid v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.44
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: PaO2:FiO2 ratio post-operative

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    End point title
    		 PaO2:FiO2 ratio post-operative
    End point description
    End point type
    Secondary
    End point timeframe
    post-operative
    End point values
    		 Ascorbic acid Placebo
    Number of subjects analysed
    13
    18
    Units: kPa
        median (inter-quartile range (Q1-Q3))
    42.5 (32.7 to 51.4)
    45.3 (28.3 to 49.4)
    Statistical analysis title
    		 PaO2:FiO2 ratio post-operative comparison of group
    Comparison groups
    Ascorbic acid v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.79
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    prior to hospital discharge
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Ascorbic acid
    Reporting group description
    		 -

    Reporting group title
    Placebo
    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: All of the adverse event were serious.
    Serious adverse events
    		 Ascorbic acid Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 13 (15.38%)
    7 / 18 (38.89%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    1
    Injury, poisoning and procedural complications
    Patient admitted to ICU from theatre due to excessive blood loss
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Bilateral femoral thromboses in setting of previous thrombotic episode associated with severe PVD
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acutely ischaemic left leg
    Additional description: Patient returned to theatre for right femoral artery surgery from recovery ward due to acutely ischaemic left leg. Vascular surgeon had noted severe left femoral arterial disease during AAA repair prior to this.
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Post operative myocardial infarction and pneumonia requiring admission to critical care
    Additional description: Both cardiac and respiratory
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    non ST elevation myocardial infarction
    Additional description: Patient with history of ischaemic heart disease diagnosed with post-operative non ST elevation myocardial infarction during planned post-operative HDU stay
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Persistent lactic acidosis and lower limb weakness and paraesthesia
    Additional description: Admitted to HDU postoperatively. Returned to theatre, required laparotomy and Hartmann's procedure for ischaemic sigmoid colon. Admitted to ICU for continued care. These sequelae could all be related to the intra-operative surgical difficulties
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Patient admitted to ICU on post op Day 2 due to Respiratory failure requiring intubation,ventilation
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patient admitted to ICU day 2 post op with respiratory failure secondary to chest sepsis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Patient developed post operative wound infection treated with intravenous antibiotics
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Ascorbic acid Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 18 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jun 2008
    To allow for ascorbic acid to be provided by an alternative manufacturer

    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/26215814
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