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    Clinical Trial Results:
    Anesthesia Induced Hormonal Oliguria Trial

    Summary
    EudraCT number
    		 2017-001646-10
    Trial protocol
    		 SE  
    Global end of trial date
    10 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Apr 2022
    First version publication date
    07 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ANIMAL-523-2014-2569
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03336801
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Uppsala University
    Sponsor organisation address
    Dept surgical sciences, Uppsala university , Uppsala, Sweden, 75185
    Public contact
    Uppsala University Hospital, Uppsala University Hospital, 46 186119209, suzanne.odeberg.wernerman@akademiska.se
    Scientific contact
    Uppsala University Hospital, Uppsala University Hospital, 46 186119209, suzanne.odeberg.wernerman@akademiska.se
    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 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jan 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate changes in renal function during general anaesthesia.
    Protection of trial subjects
    Normal clinical procedures to reduce stress and pain.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Sep 2017
    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
    Sweden: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    36
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients scheduled for elective spinal surgery were enrolled aug 2017 - jan 2020 at Uppsala University Hospital (Akademiska sjukhuset) in the preoperative ward.

    Pre-assignment
    Screening details
    		 Inclusion criteria: 18-65 years old, elective spinal surgery, signed consent. Exclusion criteria: patient refusal, pregnancy/breast feeding, allergy to anesthesia, ASA class 3-5, NYHA class 3-4, BMI >37, insulin-treated diabetes, kidney disease, liver disease, genetic malignant hyperthermia.

    Pre-assignment period milestones
    Number of subjects started
    		 36
    Number of subjects completed
    		 36

    Period 1
    Period 1 title
    Pre-anesthesia
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Propofol
    Arm description
    		 Anesthesia maintenance by propofol.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diprivan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Infusion of intravenous propofol (20 mg/ml) to maintain target controlled-infusion of 4-6 mikrog/ml.

    Arm title
    		 Sevoflurane
    Arm description
    		 Anesthesia maintenence by sevoflurane.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sevorane (Abbvie)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Sevoflurane was administered to maintain minimal alveolar concentration 0.8-1.2 at a fresh gas flow rate of 0.3-0.5 l/min.

    Number of subjects in period 1
    		Propofol Sevoflurane
    Started
    18
    18
    Completed
    16
    17
    Not completed
    2
    1
         Protocol deviation
    2
    1
    Period 2
    Period 2 title
    During anesthesia (before surgery)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Propofol
    Arm description
    		 Anesthesia maintenance by propofol.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diprivan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Infusion of intravenous propofol (20 mg/ml) to maintain target controlled-infusion of 4-6 mikrog/ml.

    Arm title
    		 Sevoflurane
    Arm description
    		 Anesthesia maintenence by sevoflurane.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sevorane (Abbvie)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Sevoflurane was administered to maintain minimal alveolar concentration 0.8-1.2 at a fresh gas flow rate of 0.3-0.5 l/min.

    Number of subjects in period 2
    		Propofol Sevoflurane
    Started
    16
    17
    Completed
    13
    14
    Not completed
    3
    3
         Consent withdrawn by subject
    -
    1
         Protocol deviation
    3
    2
    Period 3
    Period 3 title
    During postoperative care
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Propofol
    Arm description
    		 Anesthesia maintenance by propofol.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Sevoflurane
    Arm description
    		 Anesthesia maintenence by sevoflurane.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Propofol Sevoflurane
    Started
    13
    14
    Finished 2h sampling period
    13
    14
    Completed
    13
    14
    Period 4
    Period 4 title
    The day after (surgical ward)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Propofol
    Arm description
    		 Anesthesia maintenance by propofol.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Diprivan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Infusion of intravenous propofol (20 mg/ml) to maintain target controlled-infusion of 4-6 mikrog/ml.

    Arm title
    		 Sevoflurane
    Arm description
    		 Anesthesia maintenence by sevoflurane.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		Propofol Sevoflurane
    Started
    13
    14
    Finished 2h sampling period
    13
    14
    Completed
    13
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Propofol
    Reporting group description
    		 Anesthesia maintenance by propofol.

    Reporting group title
    Sevoflurane
    Reporting group description
    		 Anesthesia maintenence by sevoflurane.

    Reporting group values
    		 Propofol Sevoflurane Total
    Number of subjects
    		 18 18 36
    Age categorical
    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)
    		 18 18 36
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
        Not recorded
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 48 (43 to 53) 53 (49 to 58) -
    Gender categorical
    Units: Subjects
        Female
    		 8 6 14
        Male
    		 10 12 22
    AHA
    Units: Subjects
        Class 1
    		 12 11 23
        Class 2
    		 6 7 13
    ASA
    Units: Subjects
        Class 1
    		 13 13 26
        Class 2
    		 5 5 10
    BMI
    Units: N/A
        median (full range (min-max))
    		 27 (18 to 34) 29 (18 to 36) -

    End points

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    End points reporting groups
    Reporting group title
    Propofol
    Reporting group description
    		 Anesthesia maintenance by propofol.

    Reporting group title
    Sevoflurane
    Reporting group description
    		 Anesthesia maintenence by sevoflurane.
    Reporting group title
    Propofol
    Reporting group description
    		 Anesthesia maintenance by propofol.

    Reporting group title
    Sevoflurane
    Reporting group description
    		 Anesthesia maintenence by sevoflurane.
    Reporting group title
    Propofol
    Reporting group description
    		 Anesthesia maintenance by propofol.

    Reporting group title
    Sevoflurane
    Reporting group description
    		 Anesthesia maintenence by sevoflurane.
    Reporting group title
    Propofol
    Reporting group description
    		 Anesthesia maintenance by propofol.

    Reporting group title
    Sevoflurane
    Reporting group description
    		 Anesthesia maintenence by sevoflurane.

    Primary: Urine output

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    End point title
    		 Urine output
    End point description
    End point type
    Primary
    End point timeframe
    Urine output was measured as of induction of anesthesia and measured the last time the day after surgery.
    End point values
    		 Propofol Sevoflurane Propofol Sevoflurane Propofol Sevoflurane
    Number of subjects analysed
    13
    14
    13
    14
    13
    14
    Units: ml/kg/h
        least squares mean (standard deviation)
    1.1 ± 1.0
    0.3 ± 0.2
    1.8 ± 1.9
    1.3 ± 0.7
    2.0 ± 1.0
    1.5 ± 1.1
    Statistical analysis title
    		 Urine output
    Statistical analysis description
    2x3 repeated measurements ANOVA with Tukey's HSD
    Comparison groups
    Propofol v Sevoflurane v Propofol v Sevoflurane v Propofol v Sevoflurane
    Number of subjects included in analysis
    81
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Primary: Plasma creatinine

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    End point title
    		 Plasma creatinine
    End point description
    End point type
    Primary
    End point timeframe
    From pre-operative until the next day, 24h after surgery.
    End point values
    		 Propofol Sevoflurane Propofol Sevoflurane Propofol Sevoflurane Propofol Sevoflurane
    Number of subjects analysed
    14
    14
    13
    14
    13
    14
    13
    14
    Units: microgram(s)/millilitre
        least squares mean (standard deviation)
    67 ± 12
    76 ± 17
    63 ± 12
    74 ± 15
    68 ± 12
    81 ± 15
    62 ± 9
    71 ± 14
    Statistical analysis title
    		 Plasma creatinine
    Statistical analysis description
    2x4 repeated measurements ANOVA with Tukey's HSD
    Comparison groups
    Propofol v Sevoflurane v Propofol v Sevoflurane v Propofol v Sevoflurane v Propofol v Sevoflurane
    Number of subjects included in analysis
    109
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Plasma renin

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    End point title
    		 Plasma renin
    End point description
    End point type
    Secondary
    End point timeframe
    From pre-operatively to the next day, 24h after surgery.
    End point values
    		 Propofol Sevoflurane Propofol Sevoflurane Propofol Sevoflurane Propofol Sevoflurane
    Number of subjects analysed
    13
    14
    13
    14
    13
    14
    13
    14
    Units: mIU/L
        least squares mean (standard deviation)
    12 ± 10
    23 ± 20
    27 ± 24
    138 ± 131
    26 ± 32
    82 ± 135
    14 ± 13
    27 ± 18
    Statistical analysis title
    		 Plasma renin
    Statistical analysis description
    2x4 repeated measurement ANOVA with Bonferroni corrected planned comparisons
    Comparison groups
    Propofol v Sevoflurane v Propofol v Sevoflurane v Propofol v Sevoflurane v Propofol v Sevoflurane
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: KIM-1

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    End point title
    		 KIM-1
    End point description
    End point type
    Secondary
    End point timeframe
    From during anesthesia until the next day, 24h after surgery.
    End point values
    		 Propofol Sevoflurane Propofol Sevoflurane Propofol Sevoflurane
    Number of subjects analysed
    13
    14
    13
    14
    13
    14
    Units: picogram/milliliter
        least squares mean (standard deviation)
    959 ± 855
    1070 ± 694
    659 ± 571
    1149 ± 733
    577 ± 373
    996 ± 383
    Statistical analysis title
    		 KIM-1
    Statistical analysis description
    2x3 repeated measurements ANOVA with Tukey's HSD
    Comparison groups
    Propofol v Sevoflurane v Propofol v Sevoflurane v Propofol v Sevoflurane
    Number of subjects included in analysis
    81
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: Vasopressin

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    End point title
    		 Vasopressin
    End point description
    End point type
    Secondary
    End point timeframe
    From pre-operative to the next day, 24h after surgery.
    End point values
    		 Propofol Sevoflurane Propofol Sevoflurane Propofol Sevoflurane Propofol Sevoflurane
    Number of subjects analysed
    13
    14
    13
    14
    13
    14
    13
    14
    Units: picogram/milliliter
        least squares mean (standard deviation)
    11 ± 7
    12 ± 7
    13 ± 7
    17 ± 14
    15 ± 11
    27 ± 24
    15 ± 8
    29 ± 38
    Statistical analysis title
    		 Vasopressin
    Statistical analysis description
    2x4 repeated measurements ANOVA with Tukey's HSD
    Comparison groups
    Propofol v Sevoflurane v Propofol v Sevoflurane v Propofol v Sevoflurane v Propofol v Sevoflurane
    Number of subjects included in analysis
    108
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From the first sampling (before surgery) until the last sampling (24 hours after surgery).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    211130
    Reporting groups
    Reporting group title
    Propofol
    Reporting group description
    		 Anesthesia maintenance by propofol.

    Reporting group title
    Sevoflurane
    Reporting group description
    		 Anesthesia maintenence by sevoflurane.

    Serious adverse events
    		 Propofol Sevoflurane
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Propofol Sevoflurane
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    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 adverse events related to the trial were reported.

    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? Yes
    Date
    Interruption
    Restart date
    10 Jan 2020
    Covid-19 pandemic
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The clinical trial was terminated early due to logistical changes in the hospital because of the Covid-19 pandemic.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35279277
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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
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