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    Clinical Trial Results:
    Safety and efficacy of iloprost and eptifibatide co-administration compared to standard therapy in patients with septic shock – a randomized, controlled, double-blind investigator-initiated trial (CO-ILEPSS)

    Summary
    EudraCT number
    2014-002440-41
    Trial protocol
    DK  
    Global end of trial date
    01 Apr 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Apr 2020
    First version publication date
    30 Apr 2020
    Other versions
    Summary report(s)
    Results summary

    Trial information

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    Trial identification
    Sponsor protocol code
    CO-ILEPSS
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02204852
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Rigshospitalet, Capital Region Bloodbank 2034
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, DK-2100
    Public contact
    Sponsor (Sisse Ostrowski), Rigshospitalet, Capital Region Bloodbank 2034, Section for Transfusion Medicine, 0045 24430464, sisse.ostrowski@gmail.com
    Scientific contact
    Sponsor (Sisse Ostrowski), Rigshospitalet, Capital Region Bloodbank 2034, Section for Transfusion Medicine, 0045 24430464, sisse.ostrowski@gmail.com
    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
    23 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluating the safety and efficacy of iloprost and eptifibatide co-administration compared to placebo as an addition to standard care in septic shock patients.
    Protection of trial subjects
    The inclusion and exclusion criteria specific ensure that the patients included in this trial have a medical condition that ensure the safety for the patients e.g. platelet count more than 10,000/mm3 in the previous 24 hours; no need of blood products for bleeding in the previous 24 hours and no treatment with any antithrombotics within 12 hours. The dose used of iloprost and eptifibatide are lower than the recommended doses for their respective approved indications. The used doses are considered safety. However, stopping rules are listed in the protocol and if any of the following are seen the trial treatment will be stopped e.g. allergic reactions, severe bleeding, severe hypotension, severe hypoxia or clinically relevant thrombosis. All patients are admitted to the ICU during study treatment and will be treated according to local requirement is any SAE/SAR are seen.
    Background therapy
    All patients will receive standard of care for treatment of septic shock.
    Evidence for comparator
    The intervention is tested against standard of care. No comparator is used.
    Actual start date of recruitment
    01 Sep 2014
    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
    Denmark: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    12
    From 65 to 84 years
    11
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    The patients are recruited at the ICU at North Zealand Hospital, Denmark for a period of 20 months. Only adult patient admitted to the ICU, fulfilling the criteria for septic shock can be included. Patients are presented at the investigator site in a critical acute condition therefore a scientific guardian will co-sign the informed consent form.

    Pre-assignment
    Screening details
    All patients admitted to the ICU present with signs of septic shock are screened for inclusion. If any of the exclusion criteria are fulfilled the patient can enter the trial. A total of 509 are assessed for eligibility -n=281 not meeting inclusion criteria, n=158 due to exclusion criteria, n=29 included in another studie, n=17 missed inclusion.

    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
    Investigator, Monitor, Data analyst, Carer, Subject, Assessor
    Blinding implementation details
    The trial was a double-blind trial. Sealed envelopes are used for randomisation. Both trial medication were colourless when diluted in the saline and it was impossible to distinguish from each other. Trial medication will be handled by unblinded study nurse.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Iloprost/eptifibatide
    Arm description
    co-administration of iloprost and eptifibatide in addition to standard of care
    Arm type
    Experimental

    Investigational medicinal product name
    EPTIFIBATIDE
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    continuous co-administration of i.v infusions of 0.50 µg/kg/min eptifibatide for 48 hours.

    Investigational medicinal product name
    ILOPROST TROMETAMO
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    continuous co-administration of i.v infusions of 1.0 ng/kg/min of iloprost for 48 hours

    Arm title
    Placebo
    Arm description
    Placebo in addition to standard of care
    Arm type
    Placebo

    Investigational medicinal product name
    Saline solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients in the placebo group will receive double dummy saline infusions and will be treated exactly as active patients.

    Number of subjects in period 1
    Iloprost/eptifibatide Placebo
    Started
    15
    9
    Completed
    12
    6
    Not completed
    3
    3
         Physician decision
    1
    -
         incorret inclusion
    -
    1
         Adverse event, non-fatal
    1
    1
         transfer to other hospital
    1
    -
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    -

    Reporting group values
    Overall Trial Total
    Number of subjects
    24 24
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    12 12
        From 65-84 years
    11 11
        85 years and over
    1 1
    Gender categorical
    Overall trial
    Units: Subjects
        Female
    7 7
        Male
    17 17
    Subject analysis sets

    Subject analysis set title
    PP - Intervention group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients in the intervention group who completed the 7-day trial period

    Subject analysis set title
    PP - Placebo group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All patients who completed the 7-day trial period

    Subject analysis sets values
    PP - Intervention group PP - Placebo group
    Number of subjects
    12
    6
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    7
    3
        From 65-84 years
    5
    3
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Overall trial
    Units: Subjects
        Female
    4
    0
        Male
    8
    6

    End points

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    End points reporting groups
    Reporting group title
    Iloprost/eptifibatide
    Reporting group description
    co-administration of iloprost and eptifibatide in addition to standard of care

    Reporting group title
    Placebo
    Reporting group description
    Placebo in addition to standard of care

    Subject analysis set title
    PP - Intervention group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Patients in the intervention group who completed the 7-day trial period

    Subject analysis set title
    PP - Placebo group
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All patients who completed the 7-day trial period

    Primary: Changes in platelet count

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    End point title
    Changes in platelet count
    End point description
    Time depended changes in platelet count from baseline to 48 hours post-randomisation in the per protocol group
    End point type
    Primary
    End point timeframe
    48-hours post baseline
    End point values
    PP - Intervention group PP - Placebo group
    Number of subjects analysed
    12
    6
    Units: 10^9/L
    median (inter-quartile range (Q1-Q3))
        Platelet count - Baseline
    187.5 (130 to 254.5)
    212 (149 to 295.3)
        Platelet count - 48h
    126.5 (99 to 297.8)
    131 (109.5 to 264.3)
    Statistical analysis title
    Change in platelet count - placebo
    Statistical analysis description
    Change from baseline to 48 hours
    Comparison groups
    PP - Placebo group v PP - Intervention group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 0.049
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - Exploratory
    Statistical analysis title
    Change in platelet count - Intervention
    Statistical analysis description
    Change from baseline to 48 hours
    Comparison groups
    PP - Intervention group v PP - Placebo group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [2]
    P-value
    = 0.32
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [2] - Exploratory
    Statistical analysis title
    Change in platelet count - Time x group
    Statistical analysis description
    Change from baseline to 48 hours between groups
    Comparison groups
    PP - Intervention group v PP - Placebo group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [3]
    P-value
    = 0.83
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - Exploratory

    Primary: Change in endothelial biomarkers

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    End point title
    Change in endothelial biomarkers
    End point description
    Time-dependent change in absolute endothelial biomarker values from baseline to 48-hours
    End point type
    Primary
    End point timeframe
    At 48-hours post baseline
    End point values
    PP - Intervention group PP - Placebo group
    Number of subjects analysed
    12
    6
    Units: ng/ml
    median (inter-quartile range (Q1-Q3))
        Thrombomodulin - Baseline
    9.1 (6.6 to 17.9)
    16.1 (10.9 to 18.8)
        Thrombomodulin - 48h
    8 (5.9 to 13)
    14.6 (10.6 to 19)
        sE-Selectin - Baseline
    175.2 (82.9 to 236)
    184.9 (149.7 to 229.8)
        sE-Selectin - 48h
    161.2 (82.3 to 210)
    153.2 (132.3 to 212.5)
        Syndecan1 - Baseline
    56 (44.8 to 98)
    111.3 (55.7 to 118.1)
        Syndecan1 - 48h
    92.2 (50.9 to 110.3)
    111 (58.7 to 120.9)
        sVE-Cadherin - Baseline
    1447.2 (1391.8 to 1748.9)
    2084.9 (1917.7 to 2520.3)
        sVE-cadherin - 48h
    1530.8 (1422.4 to 1751.6)
    1934.5 (1871.1 to 2272.8)
    Statistical analysis title
    Change in Thrombomodulin from baseline to 48h
    Statistical analysis description
    Change in biomarker thrombomodulin from baseline to 48 hours post-randomisation
    Comparison groups
    PP - Placebo group v PP - Intervention group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [4]
    P-value
    = 0.851 [5]
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [4] - Exploratory
    [5] - Time x group
    Statistical analysis title
    Change in sE-Selectin from baseline to 48h
    Statistical analysis description
    Change in biomarker sE-Selectine from baseline to 48 hours post-randomisation
    Comparison groups
    PP - Intervention group v PP - Placebo group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [6]
    P-value
    = 0.659 [7]
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [6] - Exploratory
    [7] - Time x group
    Statistical analysis title
    Change in syndecan-1 from baseline to 48h
    Statistical analysis description
    Change in biomarker syndecain-1 from baseline to 48 hours post-randomisation
    Comparison groups
    PP - Intervention group v PP - Placebo group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [8]
    P-value
    = 0.566 [9]
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [8] - Exploratory
    [9] - Time x group
    Statistical analysis title
    Change in sVE-cadherin from baseline to 48h
    Statistical analysis description
    Change in biomarker sVE-cadherin from baseline to 48 hours post-randomisation
    Comparison groups
    PP - Intervention group v PP - Placebo group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [10]
    P-value
    = 0.292 [11]
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [10] - Exploratory
    [11] - Time x group

    Primary: Change in endothel biomarker - nucleosomes

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    End point title
    Change in endothel biomarker - nucleosomes
    End point description
    Time-dependent change in endothelial biomarker nucleosome
    End point type
    Primary
    End point timeframe
    At 48-hours post baseline
    End point values
    PP - Intervention group PP - Placebo group
    Number of subjects analysed
    12
    6
    Units: Percentage
    median (inter-quartile range (Q1-Q3))
        Nucleosomes - Baseline
    13.3 (4.6 to 15.4)
    7.3 (4.2 to 23.2)
        Nucleosomes - 48h
    10.8 (4.2 to 18.8)
    19.5 (11.9 to 24.2)
    Statistical analysis title
    Changes in nucleosomes (Baseline to 48h)
    Statistical analysis description
    Change i biomarker nucleosomes from baseline to 48 hours post-randomisation
    Comparison groups
    PP - Intervention group v PP - Placebo group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [12]
    P-value
    = 0.421 [13]
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [12] - Exploratory
    [13] - Time x group

    Primary: Change in D-dimer and fibrin split products

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    End point title
    Change in D-dimer and fibrin split products
    End point description
    Change in D-dimer and fibrin slit products indicative of fibrinolysis at 48-hours from baseline
    End point type
    Primary
    End point timeframe
    At 48-hours post baseline
    End point values
    PP - Intervention group PP - Placebo group
    Number of subjects analysed
    12
    6
    Units: ng/ml
    median (inter-quartile range (Q1-Q3))
        D-dimer -Baseline
    5162.8 (2339.8 to 18704.1)
    10416.9 (5365.9 to 15833.6)
        D-dimer - 48h
    8381.3 (7194.4 to 14371)
    8381.3 (7194.4 to 14371)
        FDP - Baseline
    27941.5 (19700.5 to 47360.8)
    22194 (11305.5 to 26289)
        FDP - 48h
    33594 (23067.8 to 47656.8)
    19257.5 (15305.8 to 24952.3)
        Fibrin monomer - Baseline
    75200 (25700 to 118800)
    12300 (5100 to 29900)
        Fibrin monomers - 48h
    48800 (12000 to 60400)
    15200 (4100 to 23200)
    Statistical analysis title
    Change in D-dimer (baseline to 48h)
    Statistical analysis description
    Change in D-dimer from baseline to 48 hours post-randomisation
    Comparison groups
    PP - Intervention group v PP - Placebo group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [14]
    P-value
    = 0.423 [15]
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [14] - Exploratory
    [15] - Time x group
    Statistical analysis title
    Change in FDP (baseline to 48h)
    Statistical analysis description
    Change in fibrinogen degradation products (FDP) from baseline to 48 hours post-randomisation
    Comparison groups
    PP - Intervention group v PP - Placebo group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [16]
    P-value
    = 0.502 [17]
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [16] - Exploratory
    [17] - Time x group
    Statistical analysis title
    Change in fibrin monomers (baseline to 48h)
    Statistical analysis description
    Change in fibrin monomers from baseline to 48 hours post-randomisation
    Comparison groups
    PP - Intervention group v PP - Placebo group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other [18]
    P-value
    = 0.199 [19]
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [18] - Exploratory
    [19] - Time x group

    Secondary: Mortality (ITT analysis)

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    End point title
    Mortality (ITT analysis)
    End point description
    ITT analysis of the number of patients who died at each timepoint in the 2 treatment groups
    End point type
    Secondary
    End point timeframe
    7-, 30- and 90 day mortality
    End point values
    Iloprost/eptifibatide Placebo
    Number of subjects analysed
    15
    9
    Units: Number
        7-day
    0
    2
        30-day
    2
    4
        90-day
    4
    5
    Statistical analysis title
    7-day mortality
    Comparison groups
    Iloprost/eptifibatide v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.13
    Method
    Mixed models analysis
    Confidence interval
    Statistical analysis title
    30-day mortality
    Comparison groups
    Iloprost/eptifibatide v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.15
    Method
    Mixed models analysis
    Confidence interval
    Statistical analysis title
    90-day mortality
    Comparison groups
    Iloprost/eptifibatide v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.212
    Method
    Mixed models analysis
    Confidence interval

    Secondary: Mortality (PP analysis)

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    End point title
    Mortality (PP analysis)
    End point description
    Per protocol analysis for mortality
    End point type
    Secondary
    End point timeframe
    7- , 30 and 90 day post randomisation
    End point values
    PP - Intervention group PP - Placebo group
    Number of subjects analysed
    12
    6
    Units: Number
        7-days mortality
    0
    1
        30-day mortality
    1
    2
        90-day mortality
    3
    3
    Statistical analysis title
    7-day mortality
    Comparison groups
    PP - Intervention group v PP - Placebo group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.333
    Method
    Mixed models analysis
    Confidence interval
    Statistical analysis title
    30-day mortality
    Comparison groups
    PP - Intervention group v PP - Placebo group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.254
    Method
    Mixed models analysis
    Confidence interval
    Statistical analysis title
    90-day mortality
    Comparison groups
    PP - Intervention group v PP - Placebo group
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.294
    Method
    Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From inclusion until day 90 for each patient
    Adverse event reporting additional description
    Only SAE are recorded according to the protocol
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    Data for all patients included in the intervention arm

    Reporting group title
    Placebo arm
    Reporting group description
    Data for all patients included in the placebo arm

    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: Only SAE are recorded in this trial. This is approved by the regulatory authorities.
    Serious adverse events
    Experimental arm Placebo arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 15 (26.67%)
    3 / 9 (33.33%)
         number of deaths (all causes)
    4
    5
         number of deaths resulting from adverse events
    2
    2
    Vascular disorders
    Thrombosis
    Additional description: Thrombosis in the arterial cannula
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
    Additional description: Intraabdominal bleeding after liver abscess drainage
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebral haematoma
    Additional description: Cerebral incarceration
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Bradycardia
    Additional description: Severe bradycardia (<40 mmHg) 4 hours post intervention start. Treated as cardiac arrest.
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
    Additional description: Respiratory failure 10 days after inclusion
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
    Additional description: Dead after organ failure, with terminal hepatic failure. Patient has medical history of cirrhosis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metabolism and nutrition disorders
    Enzyme level increased
    Additional description: Cardiac enzymes increasing, suspicion of type II myocardia infract
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 9 (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: 5%
    Non-serious adverse events
    Experimental arm Placebo arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 9 (0.00%)

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jun 2015
    The amendment allowed to extend the study
    16 Jan 2017
    Added measure on extra endothelial biomarkers with metabolomics.

    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.
    The septic shock definition might have limited the potential effect of the intervention, since not all patients with septic shock have equal degrees of endothelial dysfunction. Also limited power due to the small sample size is a limitation

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/31488213
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