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    Clinical Trial Results:
    CUstodiol vs RInger: whaT Is the Best Agent?

    Summary
    EudraCT number
    		 2014-003818-92
    Trial protocol
    		 IT  
    Global end of trial date
    17 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2021
    First version publication date
    29 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CURITIBA-TRIAL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02327611
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IRCCS Ospedale San Raffaele
    Sponsor organisation address
    Via Olgettina, 60, Milano, Italy, 20133
    Public contact
    UO Chirurgia Vascolare, IRCCS Ospedale San Raffaele, 0039 0226437377,
    Scientific contact
    UO Chirurgia Vascolare, IRCCS Ospedale San Raffaele, 0039 0226437377,
    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
    17 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Compare the efficacy of renal perfusion with Custodiol versus enriched Ringer's solution for renal protection in patients undergoing open thoracoabdominal aortic aneurysm (TAAA) repair
    Protection of trial subjects
    Approval by the local Ethics Committee was obtained before the beginning of the study and written informed consent was obtained from all patients at time of enrolment. Patients care was carried out by a multidisciplinary team. Except for the solutions used during the perfusion, the trial did not affect any other aspect of patient treatment, which was left to standard clinical practice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2015
    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
    Italy: 90
    Worldwide total number of subjects
    90
    EEA total number of subjects
    90
    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)
    30
    From 65 to 84 years
    60
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This prospective, single-center, randomized, double-blind, controlled, parallel trial involved 90 adult patients who were to undergo TAAA open repair surgery requiring renal perfusion. Patients were enrolled between February 2015 and january 2017. One year of follow up was completed in January 2018.

    Pre-assignment
    Screening details
    		 Patients who have participated in experimental trials during the previous 3 months, undergoing emergency/urgency intervention, patient uncooperative and/or affected by mental disease, with allergy/intolerance to the study drug, patient receiving chronic dialysis before surgery, and pregnant or breastfeeding women were excluded

    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, Carer, Assessor
    Blinding implementation details
    A computer-generated permuted block (up to a size of 10 and a 1:1 allocation) randomization sequence was used. Treatment allocation was prepared by an independent operator not otherwise involved in the trial. The patient was randomized upon operative room arrival by a CURITIBA trial staff member who prepared the blinded treatment and was not in any way involved in the clinical management of the patient. Both solutions are colorless, thus impossible to distinguish.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Custodiol Renal Perfusion
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Custodiol
    Investigational medicinal product code
    Other name
    Custodiol HTK, Histidine-tryptophan-ketoglutarate
    Pharmaceutical forms
    Solution for organ preservation
    Routes of administration
    Intraarterial use
    Dosage and administration details
    Patients randomized in the Custodiol arm received, upon renal artery clamping, a renal perfusion with cold (4°C) Custodiol. During renal ischemic time, a total of 1.5 mL of Custodiol per gram of estimated kidney weight were administered, thus implying an average of 400 mL of Custodiol for a 70-kg patient

    Arm title
    		 Ringer Renal Perfusion
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ringer's lactate
    Investigational medicinal product code
    Other name
    Lactated Ringer's solution, Sodium lactate solution
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intraarterial use
    Dosage and administration details
    Patients randomized in the enriched Ringer’s lactate arm received a renal perfusion with cold (4C) Ringer’s lactate solution enriched with 125 mg per liter of methylprednisolone and 12.5 g per liter of mannitol.

    Number of subjects in period 1
    		Custodiol Renal Perfusion Ringer Renal Perfusion
    Started
    45
    45
    Completed
    44
    44
    Not completed
    1
    1
         Intraoperative clinical reasons
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Custodiol Renal Perfusion
    Reporting group description
    		 -

    Reporting group title
    Ringer Renal Perfusion
    Reporting group description
    		 -

    Reporting group values
    		 Custodiol Renal Perfusion Ringer Renal Perfusion Total
    Number of subjects
    		 45 45 90
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.7 ± 9.82 66.4 ± 9.21 -
    Gender categorical
    Units: Subjects
        Female
    		 33 29 62
        Male
    		 12 16 28

    End points

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    End points reporting groups
    Reporting group title
    Custodiol Renal Perfusion
    Reporting group description
    		 -

    Reporting group title
    Ringer Renal Perfusion
    Reporting group description
    		 -

    Primary: Reduction of Acute renal failure (AKI)

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    End point title
    		 Reduction of Acute renal failure (AKI)
    End point description
    Make a significant reduction of acute renal failure (AKI - Defined according to the diagram 2013.9 KDIGO) in postoperative surgical patients who receive renal perfusion with Custodiol vs standard perfusion with Ringer's lactate solution
    End point type
    Primary
    End point timeframe
    28 days after surgery
    End point values
    		 Custodiol Renal Perfusion Ringer Renal Perfusion
    Number of subjects analysed
    45
    45
    Units: number of patients
        Any AKI (AKIN 1 + 2+ 3)
    22
    34
        AKIN stage 0
    23
    11
        AKIN stage 1
    11
    18
        AKIN stage 2
    7
    7
        AKIN stage 3
    4
    9
        Severe AKI (AKIN 2 +3)
    11
    16
    Statistical analysis title
    		 AKI Intention-to-treat analysis
    Comparison groups
    Custodiol Renal Perfusion v Ringer Renal Perfusion
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Lenght of stay in the Intensive care Unit (ICU)

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    End point title
    		 Lenght of stay in the Intensive care Unit (ICU)
    End point description
    End point type
    Secondary
    End point timeframe
    60 days after surgery
    End point values
    		 Custodiol Renal Perfusion Ringer Renal Perfusion
    Number of subjects analysed
    45
    45
    Units: day
        median (inter-quartile range (Q1-Q3))
    1 (1 to 2)
    1 (1 to 2)
    No statistical analyses for this end point

    Secondary: Lenght of hospitalyzation

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    End point title
    		 Lenght of hospitalyzation
    End point description
    End point type
    Secondary
    End point timeframe
    60 days after surgery
    End point values
    		 Custodiol Renal Perfusion Ringer Renal Perfusion
    Number of subjects analysed
    45
    45
    Units: day
        median (inter-quartile range (Q1-Q3))
    15 (13 to 20)
    15 (13 to 18)
    No statistical analyses for this end point

    Secondary: In-hospital mortality

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    End point title
    		 In-hospital mortality
    End point description
    End point type
    Secondary
    End point timeframe
    During hospitalization
    End point values
    		 Custodiol Renal Perfusion Ringer Renal Perfusion
    Number of subjects analysed
    45
    45
    Units: number of patients
    4
    6
    No statistical analyses for this end point

    Secondary: 1-year survival

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    End point title
    		 1-year survival
    End point description
    End point type
    Secondary
    End point timeframe
    1 year after surgery
    End point values
    		 Custodiol Renal Perfusion Ringer Renal Perfusion
    Number of subjects analysed
    45
    45
    Units: percent
        number (confidence interval 95%)
    91.1 (83 to 99)
    84.4 (74 to 95)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Until the end of the annual follow-up
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Custodiol Renal Perfusion
    Reporting group description
    		 -

    Reporting group title
    Ringer Renal Perfusion
    Reporting group description
    		 -

    Serious adverse events
    		 Custodiol Renal Perfusion Ringer Renal Perfusion
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 44 (0.00%)
         number of deaths (all causes)
    5
    6
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Custodiol Renal Perfusion Ringer Renal Perfusion
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 44 (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 non-serious adverse event associated to the IMPs were recorded

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Mar 2015
    Changes and clarifications regarding the randomization procedure Changes to some study procedures (e.g. sample collection, markers analysis, data recording)

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24377947
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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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