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    Clinical Trial Results:
    ACE inhibitor for lung protection during mechanical Ventilation for acute lung injury - pilot trial

    Summary
    EudraCT number
    		 2010-020403-75
    Trial protocol
    		 DE  
    Global end of trial date
    17 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Oct 2019
    First version publication date
    26 Oct 2019
    Other versions
    Summary report(s)
    		 final report ACEmeVent-Pilot Trial

    Trial information

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    Trial identification
    Sponsor protocol code
    ACEmeVent-Pilot
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 German Clinical Trials Register: DRKS00000156
    Sponsors
    Sponsor organisation name
    Universität Leipzig
    Sponsor organisation address
    Ritterstr. 26, Leipzig, Germany, 04109
    Public contact
    Abteilung für Pneumologie, Universität Leipzig, Department für Innere Medizin, Neurologie und Dermatologie , 49 3419712600, ACEmeVent-Pilot@zks.uni-leipzig.de
    Scientific contact
    Abteilung für Pneumologie, Universität Leipzig, Department für Innere Medizin, Neurologie und Dermatologie , 49 3419712600, ACEmeVent-Pilot@zks.uni-leipzig.de
    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 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Safety concerning renal functions and cardiovascular functions as well as the occurrence of severe adverse events. Further primary objective is efficacy of the treatment regarding the recovery of the lungs measured as ventilator free days.
    Protection of trial subjects
    Patients were closely monitored by the treating staff with regard to safety during the course of the study. In addition to the detection of adverse events, this included the collection of the following parameters on the CRF: hemodynamic parameters, organ dysfunction, safety labor parameters.
    Background therapy
    		 Standard of care
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 May 2012
    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
    Germany: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 10.05.2012 and 28.10.2015 61 patients were randomised. Three patients had to be excluded since the informed consent process failed. N=58 patients constitute the full analysis set. All these patients were followed up until death or day 60. Accrual was slower than anticipated. The initially targeted sample size of 210 was not attainable.

    Pre-assignment
    Screening details
    		 All patients diagnosed with with acute lung failure (ALI/ARDS) in participating sites included if they meet all inclusion criteria and none of the exclusion criteria applied.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Enalaprilat
    Arm description
    		 10mg Enalaprilat as injection solution in injection vials (10ml) or the preparation of an infusion solution (50ml). One injection vial corresponds to one daily dose. Total amount for one patient for a maximum of 28 days trial therapy and two additional daily doses as reserve.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Enalaprilat
    Investigational medicinal product code
    Other name
    Enahexal
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    10mg as injection solution in injection vials (10 ml) for the preparation of an infusion solution (50 ml).

    Arm title
    		 Placebo
    Arm description
    		 sodium chloride solution (0,9 %) in injection vials (10 ml) for the preparation of an infusion solution (50 ml). One injection vial corresponds to one daily dose. Total amount for one patient for a maximum of 28 days trial therapy and two additional daily doses as a reserve.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    sodium chloride solution (0,9 %) in injection vials (10 ml) for the preparation of an infusion solution (50 ml)

    Number of subjects in period 1
    		Enalaprilat Placebo
    Started
    29
    29
    Completed
    29
    29

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Enalaprilat
    Reporting group description
    		 10mg Enalaprilat as injection solution in injection vials (10ml) or the preparation of an infusion solution (50ml). One injection vial corresponds to one daily dose. Total amount for one patient for a maximum of 28 days trial therapy and two additional daily doses as reserve.

    Reporting group title
    Placebo
    Reporting group description
    		 sodium chloride solution (0,9 %) in injection vials (10 ml) for the preparation of an infusion solution (50 ml). One injection vial corresponds to one daily dose. Total amount for one patient for a maximum of 28 days trial therapy and two additional daily doses as a reserve.

    Reporting group values
    		 Enalaprilat Placebo Total
    Number of subjects
    		 29 29 58
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 20 15 35
        From 65-84 years
    		 9 14 23
        85 years and over
    		 0 0 0
        NA
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.9 ± 14.1 63.1 ± 13.0 -
    Gender categorical
    Units: Subjects
        Female
    		 5 6 11
        Male
    		 24 23 47
        NA
    		 0 0 0
    Acute lung injury
    Units: Subjects
        yes
    		 29 29 58
        no
    		 0 0 0
        NA
    		 0 0 0
    ACE-inhibitors (within the last 7 days)
    Units: Subjects
        yes
    		 2 8 10
        no
    		 27 21 48
        NA
    		 0 0 0
    Cause of acute lung injury
    Units: Subjects
        Pneumonia
    		 19 14 33
        Sepsis
    		 3 7 10
        Aspiration
    		 3 6 9
        Trauma
    		 1 0 1
        Transfusion related lung injury
    		 0 0 0
        Other
    		 3 2 5
        NA
    		 0 0 0
    AT1 blockers
    Units: Subjects
        yes
    		 4 7 11
        no
    		 25 22 47
        NA
    		 0 0 0
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 175 ± 9 172 ± 8 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 84 ± 15 83 ± 18 -
    Urine output
    Units: ml/24h
        arithmetic mean (standard deviation)
    		 1771 ± 1349 2140 ± 1610 -
    Maximal body temperature
    Units: degree Celsius
        arithmetic mean (standard deviation)
    		 38 ± 1 38 ± 1 -
    Arterial paCO2
    Units: mmHG
        arithmetic mean (standard deviation)
    		 46.6 ± 11.2 66.4 ± 64.2 -
    Arterial paO2
    Units: mmHg
        arithmetic mean (standard deviation)
    		 88.4 ± 41.8 92.9 ± 35.0 -
    FiO2
    Units: percent
        arithmetic mean (standard deviation)
    		 0.7 ± 0.2 0.7 ± 0.2 -
    paO2/FiO2
    Units: ratio
        arithmetic mean (standard deviation)
    		 122.0 ± 61.8 141.4 ± 59.9 -

    End points

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    End points reporting groups
    Reporting group title
    Enalaprilat
    Reporting group description
    		 10mg Enalaprilat as injection solution in injection vials (10ml) or the preparation of an infusion solution (50ml). One injection vial corresponds to one daily dose. Total amount for one patient for a maximum of 28 days trial therapy and two additional daily doses as reserve.

    Reporting group title
    Placebo
    Reporting group description
    		 sodium chloride solution (0,9 %) in injection vials (10 ml) for the preparation of an infusion solution (50 ml). One injection vial corresponds to one daily dose. Total amount for one patient for a maximum of 28 days trial therapy and two additional daily doses as a reserve.

    Primary: Ventilator free days

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    End point title
    		 Ventilator free days
    End point description
    Primary efficacy endpoint. Every complete day alive and without mechanical ventilation between day 0 and day 28.
    End point type
    Primary
    End point timeframe
    28 days
    End point values
    		 Enalaprilat Placebo
    Number of subjects analysed
    29
    29
    Units: days
        arithmetic mean (standard deviation)
    12.3 ± 10.7
    8.7 ± 10.1
    Statistical analysis title
    		 Primary efficacy: ventilator free days
    Statistical analysis description
    comparison of ventilator-free days in the intention to treat population
    Comparison groups
    Enalaprilat v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.185
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.12
         upper limit
    		 1.81

    Primary: Renal replacement therapy free days

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    End point title
    		 Renal replacement therapy free days
    End point description
    primary safety endpoint
    End point type
    Primary
    End point timeframe
    28 days
    End point values
    		 Enalaprilat Placebo
    Number of subjects analysed
    29
    29
    Units: days
        arithmetic mean (standard deviation)
    20 ± 11
    19 ± 11
    Statistical analysis title
    		 Primary: Renal replacement therapy free days
    Statistical analysis description
    primary safety analysis
    Comparison groups
    Enalaprilat v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.79
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Days alive outside ICU

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    End point title
    		 Days alive outside ICU
    End point description
    Secondary efficacy endpoint
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 Enalaprilat Placebo
    Number of subjects analysed
    29
    29
    Units: days
        arithmetic mean (standard deviation)
    8.9 ± 9.4
    4.9 ± 8
    Statistical analysis title
    		 Secondary: days alive outside ICU
    Statistical analysis description
    secondary efficacy analysis
    Comparison groups
    Enalaprilat v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.086
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.6
         upper limit
    		 0.6

    Secondary: Overall survival d28

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    End point title
    		 Overall survival d28
    End point description
    Secondary efficacy endpoint
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 Enalaprilat Placebo
    Number of subjects analysed
    29
    29
    Units: patient
        dead
    6
    5
        alive
    23
    24
    Statistical analysis title
    		 Secondary: overall survival d28
    Comparison groups
    Enalaprilat v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Overall survival d60

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    End point title
    		 Overall survival d60
    End point description
    Secondary efficacy endpoint
    End point type
    Secondary
    End point timeframe
    60 days
    End point values
    		 Enalaprilat Placebo
    Number of subjects analysed
    29
    29
    Units: patients
        dead
    7
    6
        alive
    22
    23
    Statistical analysis title
    		 Secondary: overall survival d60
    Statistical analysis description
    secondary efficacy analysis
    Comparison groups
    Placebo v Enalaprilat
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Days without organ failure

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    End point title
    		 Days without organ failure
    End point description
    Secondary efficacy endpoint. Days alive without organ failure (except lung)
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 Enalaprilat Placebo
    Number of subjects analysed
    29
    29
    Units: days
        arithmetic mean (standard deviation)
    20.1 ± 9.6
    21.7 ± 9.1
    Statistical analysis title
    		 Secondary: days without organ failure
    Statistical analysis description
    secondary efficacy analysis
    Comparison groups
    Enalaprilat v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.498
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Renal replace-ment therapy d60

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    End point title
    		 Renal replace-ment therapy d60
    End point description
    Restricted on patients alive at day 60.
    End point type
    Secondary
    End point timeframe
    day 60
    End point values
    		 Enalaprilat Placebo
    Number of subjects analysed
    22
    23
    Units: patients
        renal replacement therapy
    1
    1
    No statistical analyses for this end point

    Secondary: Mean daily fluid balance

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    End point title
    		 Mean daily fluid balance
    End point description
    Secondary safety analysis
    End point type
    Secondary
    End point timeframe
    days 1-5
    End point values
    		 Enalaprilat Placebo
    Number of subjects analysed
    29
    29
    Units: ml
        arithmetic mean (standard deviation)
    343 ± 1644
    291 ± 1248
    Statistical analysis title
    		 Secondary: mean daily fluid balance
    Statistical analysis description
    Secondary safety analysis
    Comparison groups
    Enalaprilat v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.89
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Vasoactive substance free days

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    End point title
    		 Vasoactive substance free days
    End point description
    secondary safety endpoint
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 Enalaprilat Placebo
    Number of subjects analysed
    29
    29
    Units: days
        arithmetic mean (standard deviation)
    16.4 ± 10.5
    16.1 ± 9.9
    Statistical analysis title
    		 Secondary: vasoactive substance free days
    Statistical analysis description
    secondary safety analysis
    Comparison groups
    Enalaprilat v Placebo
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.89
    Method
    		 t-test, 2-sided
    Confidence interval

    Other pre-specified: Ventilator free days in per-protocol population

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    End point title
    		 Ventilator free days in per-protocol population
    End point description
    Sensitivity analysis for the primary efficacy endpoint in the per-protocol-population. Every complete day alive and without mechanical ventilation between day 0 and day 28 is counted.
    End point type
    Other pre-specified
    End point timeframe
    28 days
    End point values
    		 Enalaprilat Placebo
    Number of subjects analysed
    24
    22
    Units: days
        arithmetic mean (standard deviation)
    12.5 ± 10.7
    6.8 ± 9.5
    Statistical analysis title
    		 Sensitivity analysis for primary efficacy endpoint
    Statistical analysis description
    Several patients received additional, oral ACE Inhibitors violating the protocol. 7 patients in the Placebo arm and 5 patients in the Enalaprilat arm were treated with additional oral ACE Inhibitors. Duration of treatment with additional ACE inhibitor was 13.7±10.9 days in the Placebo and 4.6±7 days in the Enalaprilat arms (p=0.108). Since these numbers are not negligible these patients are excluded in a per-protocol sensitivity analysis.
    Comparison groups
    Enalaprilat v Placebo
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.06
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24h after last study drug administration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Enalaprilat
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Enalaprilat Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 29 (27.59%)
    12 / 29 (41.38%)
         number of deaths (all causes)
    7
    6
         number of deaths resulting from adverse events
    7
    5
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prothrombin time prolonged
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Procedural haemorrhage
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Low cardiac output syndrome
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Blood and lymphatic system disorders
    Coagulopathy
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Gastrointestinal disorders
    Intestinal ischaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic ischaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         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
    Hypercapnia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Septic shock
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Lactic acidosis
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Metabolic acidosis
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    1 / 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
    		 Enalaprilat Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 29 (86.21%)
    25 / 29 (86.21%)
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Haemoglobin decreased
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    3
    Platelet count decreased
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Vascular disorders
    Haemodynamic instability
         subjects affected / exposed
    8 / 29 (27.59%)
    2 / 29 (6.90%)
         occurrences all number
    10
    3
    Hypertension
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    5
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    3
    Cardiac arrest
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
         occurrences all number
    3
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences all number
    9
    0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Pyrexia
         subjects affected / exposed
    6 / 29 (20.69%)
    2 / 29 (6.90%)
         occurrences all number
    7
    3
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 29 (10.34%)
         occurrences all number
    1
    3
    Delirium
         subjects affected / exposed
    2 / 29 (6.90%)
    4 / 29 (13.79%)
         occurrences all number
    2
    4
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    4 / 29 (13.79%)
    2 / 29 (6.90%)
         occurrences all number
    4
    2
    Infections and infestations
    Sepsis
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    2
    3
    Metabolism and nutrition disorders
    Hypernatraemia
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 29 (6.90%)
         occurrences all number
    3
    2
    Hypophosphataemia
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    Metabolic acidosis
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jul 2012
    Exclusion criteria regarding contraindication for therapy to be used are changed: Exclusion criteria "severe renal dysfunction" and "patients with renal replacement therapy" are deleted.
    09 Oct 2013
    more precise definition of inclusion and exclusion criteria: 1. Presence of invasive mechanical ventilation and start of ventilation no longer than 60 hours ago (previously 48 hours) 2. Age at least 18 years (previously: age between 18 until 80 years) 3. patients a. after bone marrow or stem cell transplantation within the last 12 months b. after lung transplantation (previously: Patients after bone marrow, stem cell or lung transplantation)
    05 Feb 2015
    Minor adjustments to the trial protocol: for example: The project accompanying the investigation of the ACE gene polymorphism of the study has so far not been sufficiently distinguished from the study question in the trial protocol. Duration of the trial customized, because the recruitment was delayed and was expected to end in late 2015 following the recruitment of 60 patients as recommended by the DMC. Supplementing the safety endpoint: Change in renal function (CREA) by day 28

    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 recruitment was delayed and was expected to end in late 2015 following the recruitment of 60 patients (planned: 210 patients) as recommended by the DMC.
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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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