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    Clinical Trial Results:
    RANDOMIZED CONTROLLED TRIAL OF THE EFFECTS OF PARENTERAL FISH OIL EMULSION UPON SURVIVAL OUTCOME OF CRITICALLY ILL SEPTIC PATIENTS IN THE INTENSIVE CARE UNIT

    Summary
    EudraCT number
    		 2009-016880-13
    Trial protocol
    		 GB  
    Global end of trial date
    10 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2020
    First version publication date
    26 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ITU version1 19/10/2009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospitals of Leicester
    Sponsor organisation address
    Research and Innovation. Leicester General Hospital, Gwendolen Road, Leicester, United Kingdom, LE5 4PW
    Public contact
    Carolyn Maloney Head of Operations R&D Office. Leicester General Hospital LE5 4PW, University Hospitals of Leicester NHS Trust , + 44 116 2588110, ashley.dennison@uhl-tr.nhs.uk
    Scientific contact
    Mr Ashley Dennison Department of Hepatobiliary Surgery Leicester General Hospital LE5 4PW, University Hospitals of Leicester NHS Trust , + 44 116 2588110, ashley.dennison@uhl-tr.nhs.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
    01 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The effect of Omega 3 fatty acids on reduction of APACHE II score as a surrogate marker of mortality.
    Protection of trial subjects
    The infusion of omegaven can cause a prolonged bleeding time and an inhibited platelet aggregation. Therefore shoudl be administered with caustion to patients requiring anti platelet therapy even with regard to a possible reduction of anticoagulants. There are no otehr known interactions. Coagulations screens were performed on all subjects prior to recruitment and undertaken daily (as part of routien care) during the progress of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 May 2011
    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
    United Kingdom: 74
    Worldwide total number of subjects
    74
    EEA total number of subjects
    74
    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)
    35
    From 65 to 84 years
    34
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment 10.07.11 to 03.04.14. Single UK Centre Participants will be identified by the direct care team on the intensive care unit, who will refer the patients to the researchers for consideration of enrolling in the study.

    Pre-assignment
    Screening details
    		 All critically ill septic patients admitted to the intensive care unit at Leicester General and Glenfield Hospital and the high dependency renal unit. Sepsis is defined as a systemic inflammatory response syndrome(SIRS) (Annexe 3) and the presence of a known of suspected infection.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1
    Arm description
    		 Omegaven Fish Oil Infusion
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omegaven emulsion for infusion
    Investigational medicinal product code
    PR4
    Other name
    Pharmaceutical forms
    Emulsion for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.5mls omegaven per kilogram of body weight/hour corresponding to 0.05gms fish oil per kilogram of body weight per hour. Total dose 0.05gram/0.5ml intravenous

    Arm title
    		 ARM 2
    Arm description
    		 Standard Care
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Arm 1 ARM 2
    Started
    35
    39
    Completed
    35
    39

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 Omegaven Fish Oil Infusion

    Reporting group title
    ARM 2
    Reporting group description
    		 Standard Care

    Primary: Effect of Omega 3 fatty acids on the number of new organ dysfunction(not present at baseline/admission) as a predictor for teh outcome in sepsis

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    End point title
    		 Effect of Omega 3 fatty acids on the number of new organ dysfunction(not present at baseline/admission) as a predictor for teh outcome in sepsis
    End point description
    End point type
    Primary
    End point timeframe
    pts observed over a maximum of 2 weeks
    End point values
    		 Arm 1 ARM 2
    Number of subjects analysed
    30
    30
    Units: numbers
        arithmetic mean (standard deviation)
    30 ± 30
    30 ± 30
    Statistical analysis title
    		 stata software
    Comparison groups
    Arm 1 v ARM 2
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Parameter type
    		 linear regression
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0.04
         upper limit
    		 -

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Timepoint for reporting is until discharge from ITU/HDU or for a maximum period of 14 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    ARM1
    Reporting group description
    		 -

    Reporting group title
    ARM2
    Reporting group description
    		 Standard Care

    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: No non-serious adverse events were recorded for this study
    Serious adverse events
    		 ARM1 ARM2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 35 (11.43%)
    6 / 39 (15.38%)
         number of deaths (all causes)
    3
    6
         number of deaths resulting from adverse events
    3
    6
    General disorders and administration site conditions
    Multi organ failure
         subjects affected / exposed
    4 / 35 (11.43%)
    6 / 39 (15.38%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 6
    Skin and subcutaneous tissue disorders
    Rash and Bruising
    Additional description: Bruising and rash on arms legs and chest. Clotting was checked and normal.
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Renal Failure
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ARM1 ARM2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 39 (0.00%)

    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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    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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