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    Clinical Trial Results:
    The safety and feasibility of administering xenon to patients undergoing off-pump coronary artery bypass graft surgery: a pilot study XOPCAB – Xenon in Off-Pump Coronary Artery Bypass Grafting

    Summary
    EudraCT number
    2012-002316-12
    Trial protocol
    BE  
    Global end of trial date
    14 Jan 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    SR052012
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01757106
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University Hospitals Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Anesthesia Research, University Hospitals of the KU Leuven, 0032 016344620, christel.huygens@uzleuven.be
    Scientific contact
    Anesthesia Research, University Hospitals of the KU Leuven, 0032 016344620, christel.huygens@uzleuven.be
    Sponsor organisation name
    University Hospitals Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Christel Huygens, Department of Anesthesiology, University Hospitals Leuven, 0032 16344720, christel.huygens@uzleuven.be
    Scientific contact
    Christel Huygens, Department of Anesthesiology, University Hospitals Leuven, 0032 16344720, christel.huygens@uzleuven.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
    14 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jul 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to assess whether opioid-based xenon-anaesthesia is non-inferior to opioid-based sevoflurane anaesthesia in terms of haemodynamic stability (as reflected by vasopressor requirements). Secondary aims of the study included the assessment of various perioperative safety parameters.
    Protection of trial subjects
    The interventional treatment was administered to patients under advanced hemodynamic monitoring in the setting of a fully equipped cardiac surgical operating room. This enables immediate detection and treatment of adverse events. Xenon inhalation was immediately stopped in case that the study patient shows a life-threatening deterioration. After leaving the operation room, all patients were closely monitored by the study team for the occurrence of eventual adverse or serious adverse events (S) AE’s during the whole postoperative period until hospital discharge. Moreover, the inclusion of each individual patient into the study was indicated in the electronic hospital information system and hence visible to all physicians and nurses involved in the care of this patient. This facilitates reporting of (S)AE’s to the principal investigator. Finally, suspected unexpected serious adverse reactions were reported by the principal investigator to the federal health authorities.
    Background therapy
    In noncardiac surgery, the noble gas xenon has been reported to produce only minimal haemodynamic side effects when compared with other anaesthetics, even in high-risk cardiovascular patients. These observations were confirmed by multicentre randomized controlled trials in which xenon was compared with isoflurane and was found to slightly decrease heart rate and to preserve or moderately increase arterial pressures. Such haemodynamic effects may result in an overall improvement of the balance between myocardial oxygen delivery and consumption.
    Evidence for comparator
    Wappler F, Rossaint R, Baumert J, et al. Multicenter randomized comparison of xenon and isoflurane on left ventricular function in patients undergoing elective surgery. Anesthesiology 2007; 106: 463–71. Rossaint R, Reyle-Hahn M, Schulte Am Esch J, et al. Multicenter randomized comparison of the efficacy and safety of xenon and isoflurane in patients undergoing elective surgery. Anesthesiology 2003; 98: 6–13. Stoppe C, Fahlenkamp AV, Rex S, et al. Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study. Br J Anaesth 2013; 111: 406–16.
    Actual start date of recruitment
    03 Dec 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    7
    From 65 to 84 years
    33
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    After obtaining written informed consent, 42 patients scheduled for elective OPCAB surgery were enrolled in this prospective, single-centre, randomized, single-blinded, controlled pilot study. Patients recruitment started in December 2012 to July 2013, 79 patients scheduled for elective OPCAB surgery were screened.

    Pre-assignment
    Screening details
    Patients could be included if they were >18 years, scheduled for elective OPCAB surgery. Exclusion criteria were: lack of informed consent; chronic obstructive pulmonary disease(GOLD) stage >II; renal dysfunction, defined as serum creatinine >1.5mg/dl; acute coronary syndrome during the last 24h; LV EF≤30%; MMSE < 25, delirium at baseline, etc.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject
    Blinding implementation details
    A masked randomization procedure using sealed, opaque, sequentially numbered envelopes that were opened only upon arrival of the patient in the operating room (OR). Investigator I completed patient enrolment & postoperative follow-ups & was, like the patient, blinded to the study group. Investigator II performed randomization and general anaesthesia for OPCAB surgery and could not be blinded due to administration of the anaesthetic via a dedicated anaesthesia machine & the mandatory monitoring.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Sevoflurane group
    Arm description
    sevoflurane1.0 1.4% in oxygen and medicalair (FO2 =0.3–0.4).
    Arm type
    Active comparator

    Investigational medicinal product name
    Sevoflurane
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    EEG-titrated administration via inhalation via endotracheal tube

    Arm title
    Xenon group
    Arm description
    xenon 50–60% in oxygen [fraction of inspired oxygen (FO2 = 0.3–0.4)] .
    Arm type
    Experimental

    Investigational medicinal product name
    Xenon
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    EEG-titrated application via inhalation via endotracheal tube

    Number of subjects in period 1
    Sevoflurane group Xenon group
    Started
    21
    21
    Completed
    21
    21

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sevoflurane group
    Reporting group description
    sevoflurane1.0 1.4% in oxygen and medicalair (FO2 =0.3–0.4).

    Reporting group title
    Xenon group
    Reporting group description
    xenon 50–60% in oxygen [fraction of inspired oxygen (FO2 = 0.3–0.4)] .

    Reporting group values
    Sevoflurane group Xenon group Total
    Number of subjects
    21 21 42
    Age categorical
    Patients could be included if they were >18 years of age and scheduled for elective OPCAB surgery.
    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)
    8 7 15
        From 65-84 years
    11 13 24
        85 years and over
    2 1 3
    Age continuous
    Patients could be included if they were >18 years of age and scheduled for elective OPCAB surgery.
    Units: years
        median (full range (min-max))
    68 (47 to 86) 68 (55 to 84) -
    Gender categorical
    Units: Subjects
        Female
    4 5 9
        Male
    17 16 33

    End points

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    End points reporting groups
    Reporting group title
    Sevoflurane group
    Reporting group description
    sevoflurane1.0 1.4% in oxygen and medicalair (FO2 =0.3–0.4).

    Reporting group title
    Xenon group
    Reporting group description
    xenon 50–60% in oxygen [fraction of inspired oxygen (FO2 = 0.3–0.4)] .

    Primary: Hemodynamic stability

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    End point title
    Hemodynamic stability
    End point description
    The primary outcome was the dose of noradrenaline that was required intraoperatively to achieve the predefined haemodynamic goals (Mean arterial pressure > 65 mmHg).
    End point type
    Primary
    End point timeframe
    Start of anaesthesia induction to end surgery (Intraoperatively)
    End point values
    Sevoflurane group Xenon group
    Number of subjects analysed
    21
    21
    Units: µg
        median (inter-quartile range (Q1-Q3))
    1700 (1320 to 3160)
    470 (320 to 740)
    Statistical analysis title
    Primary outcome
    Comparison groups
    Xenon group v Sevoflurane group
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    P-value
    < 0.05
    Method
    t-test, 2-sided
    Confidence interval
    Notes
    [1] - For the statistical analysis of the primary outcome, a 95% confidence interval (CI) was constructed for the ratio of the (geometric) mean comparing the intraoperative noradrenaline consumption of xenon with sevoflurane. For a single patient in the xenon group that did not require noradrenaline at all, the minimal observed consumption was assumed to allow the necessary log transformation.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Patients randomization - hospital discharge
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Sevoflurane group
    Reporting group description
    sevoflurane1.0 1.4% in oxygen and medicalair (FO2 =0.3–0.4).

    Reporting group title
    Xenon group
    Reporting group description
    xenon 50–60% in oxygen [fraction of inspired oxygen (FO2 = 0.3–0.4)] .

    Serious adverse events
    Sevoflurane group Xenon group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 21 (14.29%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Ventricular arrhythmia
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Stroke
    Additional description: Cerebrovascular accident
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 21 (4.76%)
         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: 5%
    Non-serious adverse events
    Sevoflurane group Xenon group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 21 (76.19%)
    13 / 21 (61.90%)
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    7 / 21 (33.33%)
    8 / 21 (38.10%)
         occurrences all number
    7
    8
    pericardial tamponade
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 21 (4.76%)
         occurrences all number
    2
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 21 (9.52%)
         occurrences all number
    2
    2
    Sepsis
         subjects affected / exposed
    6 / 21 (28.57%)
    2 / 21 (9.52%)
         occurrences all number
    6
    2

    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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