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    Clinical Trial Results:
    (Feasibility) Open label Randomised Controlled Trial of Hyperoxic O2 Therapy vs. Normoxic O2 Therapy in Sepsis

    Summary
    EudraCT number
    2015-000629-35
    Trial protocol
    GB  
    Global end of trial date
    10 Nov 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    31 May 2019
    First version publication date
    31 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Version 2.2; March 2016
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02378545
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    IRAS No.: 171788, R&D No.: 15/P/020, REC No.: 15/WM/0175
    Sponsors
    Sponsor organisation name
    University Hospitals Plymouth NHS Trust (previously known as Plymouth Hospitals NHS Trust)
    Sponsor organisation address
    Research Office, L2 MSCP, Bircham Park Offices, 1 Roscoff Rise, Derriford, Plymouth, United Kingdom, PL6 5FP
    Public contact
    Dr Chris Rollinson, Research Governance Mananger, University Hospitals Plymouth NHS Trust, 01752 432842, c.rollinson@nhs.net
    Scientific contact
    Dr Tim Nutbeam, Consultant in Emergency Medicine, University Hospitals Plymouth NHS Trust, 01752 437629, timnutbeam@nhs.net
    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
    10 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the feasibility of a study which answers the question: “In adult patients with sepsis presenting to the emergency department by ambulance does delivery of high flow oxygen (hyperoxic oxygen therapy) compared to titrated (normoxic) oxygen therapy reduce mortality at 90 days” NB. Mortality at 90 days (note: this is a feasibility study, multiple outcomes are of relevance in informing the definitive study).
    Protection of trial subjects
    The study is approved by the MHRA and the West Midlands - Edgbaston Research Ethics Committee (NRES). Study monitoring is conducted by UHPNT and an Independent Trial Steering Committee (TSC), Trial Management Group (TMG) and Data Monitoring Committee (DMC) are set up for the study oversight.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 May 2015
    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: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    19
    From 65 to 84 years
    25
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    Patients with sepsis arriving by ambulance to Derriford Emergency Department. Routine assessment confirms patient has possible sepsis (SIRS + presence of infection). Patient assessed for the trial eligibility. If eligible informed consent is taken. Patient randomised to receive either Hyperoxia or Normoxia.

    Pre-assignment
    Screening details
    Patients with baseline observations outside of the normal limits will be screened for trial participation. Screening consists of a 4 steps: Is SIRS present? Does the participant have an active or presumed Infection? Is a sepsis MIMIC more likely to be the cause of this participant’s presentation to hospital? Do any other EXCLUSION criteria exist?

    Pre-assignment period milestones
    Number of subjects started
    50
    Number of subjects completed
    50

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Hyperoxia
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Oxygen (Hyperoxia)
    Investigational medicinal product code
    Other name
    Medical Oxygen
    Pharmaceutical forms
    Medicinal gas, compressed
    Routes of administration
    Inhalation use
    Dosage and administration details
    Oxygen will be administered using a non-re-breathe oxygen mask applied over the face and nose. The oxygen delivery device will be set to deliver oxygen at 15 litres per minute. The oxygen will be continuously delivered throughout the patients stay in the Emergency Department.

    Arm title
    Normoxia
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Oxygen (normoxia)
    Investigational medicinal product code
    Other name
    Medical Oxygen
    Pharmaceutical forms
    Medicinal gas, compressed
    Routes of administration
    Inhalation use
    Dosage and administration details
    Oxygen will not be administered if a patient’s oxygen saturations (as measured using a pulse oximeter) are 94%. If a patient’s oxygen saturations are less than 94%, oxygen will be ‘titrated’ using a ‘venturi’ type oxygen delivery device to achieve target saturations of 94%. Following initial dynamic titration (to identify correct oxygen delivery level) the oxygen delivery device will be re-evaluated hourly during the patient’s stay in the emergency department.

    Number of subjects in period 1
    Hyperoxia Normoxia
    Started
    25
    25
    Completed
    25
    25

    Baseline characteristics

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

    Reporting group title
    Normoxia
    Reporting group description
    -

    Reporting group values
    Hyperoxia Normoxia Total
    Number of subjects
    25 25 50
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    69.32 ± 16.64 59.12 ± 22.83 -
    Gender categorical
    Units: Subjects
        Female
    18 12 30
        Male
    7 13 20

    End points

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

    Reporting group title
    Normoxia
    Reporting group description
    -

    Primary: Mortality at 90 days

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    End point title
    Mortality at 90 days [1]
    End point description
    The primary endpoint/outcome is mortality at 90 days. This is a feasibility study, multiple outcomes are of relevance in informing the definitive study: Can the study procedures be implemented as planned; Recruitment rate, characteristics of patients not recruited; Drop-out rate and reasons for drop out; Data collection success / missing data; Additional currently unidentified costs; Adequacy of follow up arrangements / number of patients lost to follow up; Collect data to identify survival and quality of life differences which may inform power calculation and primary outcome for the definitive study; Optimal hours for patient recruitment; Identification of unexpected adverse events / reactions; Identify patients for patient and public involvement.
    End point type
    Primary
    End point timeframe
    Visit 4 - follow up at 90 days.
    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: This study is a feasibility study using descriptive statistics, therefore not powered to complete inferential statistics.
    End point values
    Hyperoxia Normoxia
    Number of subjects analysed
    25
    23
    Units: Number of people
    25
    23
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All SAEs, SARs including SUSARs are reported to the RD Office (sponsor) within 24 hours. RD Office to report to MHRA and REC within 7 days if fatal or life-threatening and all other SUSARs within 15 days.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19
    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: This patient group had sepsis and were seriously ill and incapacitated. No adverse events were reported at the 90 day follow-up.

    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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