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    Clinical Trial Results:
    Effect of a preinterventional calorie restriction on renal function after contrast agent exposition in patients at risk.

    Summary
    EudraCT number
    		 2012-003696-18
    Trial protocol
    		 DE  
    Global end of trial date
    07 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Dec 2020
    First version publication date
    26 Dec 2020
    Other versions
    Summary report(s)
    		 Final_Report_2020-03-12

    Trial information

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    Trial identification
    Sponsor protocol code
    uni-koeln-1547
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01879839
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 DRKS: 00004361
    Sponsors
    Sponsor organisation name
    University of Cologne
    Sponsor organisation address
    Albertus-Magnus-Platz, Cologne, Germany, 50923
    Public contact
    Clinic II Internal Medicine PD. Dr. V Burst, University Hospital of Cologne, 0049 22147897222, volker.burst@uk-koeln.de
    Scientific contact
    Clinic II Internal Medicine PD. Dr. V Burst, University Hospital of Cologne, 0049 22147897222, volker.burst@uk-koeln.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
    07 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The intention of this trial is to investigate, if a short-term calorie restriction before contrast agent administration can prevent contrast induced nephropathy.
    Protection of trial subjects
    Increase of creatinine in serum [mg/dl] 48 h after coronary intervention compared with creatinine in serum on day 0 before intervention
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jul 2013
    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
    Germany: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    5
    From 65 to 84 years
    73
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient in: 10.07.2013 Last patient out: 07.10.2016

    Pre-assignment
    Screening details
    		 Inclusion: Patients with planned coronary intervetion and following diagnosis: pAVK, Creatinine >1,1 (m)/>0,9 (w), diabetes, hart failure with NYHA 3-4, signed consent Exclusion: end stage kidney failure, kidney transplantation, underweight or obese, infection, allergy on ingredients of formula-diet, paricipation on another clinical trials

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Diet arm
    Arm description
    		 Patients will receive special nutrition 4 days before the coronary intervention (day -4 till breakfast of day -1), afterwards fasting till coronary intervention on day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fresubin® energy fibre Drink (Fresenius Kabi Deutschland GmbH, Bad Homburg, Deutschland).
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    Patients get Fresubin® energy fibre Drink for three days vor intervetion and morning of day -1 (from day -4 till morning of day -1)

    Investigational medicinal product name
    Accupaque™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Dosage and administration according standard care of department III of University Hospital of Cologne

    Arm title
    		 Control Arm
    Arm description
    		 Patients will allowed to eat ad libitum, they have any changes in their eating habits
    Arm type
    		 comparator

    Investigational medicinal product name
    Accupaque™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Dosage and administration according standard care of department III of University Hospital of Cologne

    Number of subjects in period 1
    		Diet arm Control Arm
    Started
    40
    40
    Completed
    40
    40

    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
    		 80 80
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 73 73
        85 years and over
    		 2 2
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 60 60

    End points

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    End points reporting groups
    Reporting group title
    Diet arm
    Reporting group description
    		 Patients will receive special nutrition 4 days before the coronary intervention (day -4 till breakfast of day -1), afterwards fasting till coronary intervention on day 0.

    Reporting group title
    Control Arm
    Reporting group description
    		 Patients will allowed to eat ad libitum, they have any changes in their eating habits

    Primary: Increase of creatinine in serum 48 h after coronary intervention (exposure of contrast agent )

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    End point title
    		 Increase of creatinine in serum 48 h after coronary intervention (exposure of contrast agent )
    End point description
    End point type
    Primary
    End point timeframe
    48 h after coronary intervention (exposure of contrast agent)
    End point values
    		 Diet arm Control Arm
    Number of subjects analysed
    34
    33
    Units: mg/dl
        arithmetic mean (standard deviation)
    0.078 ( 0.35 )
    0.127 ( 0.21 )
    Statistical analysis title
    		 ANCOVA with Covariate Baseline-Creatinine
    Statistical analysis description
    The difference between serum creatinine 48h after the start of coronary intervention (contrast medium exposure) and serum creatinine on Day 0 before intervention is compared in the two trial groups by means of ANCOVA (baseline adjustment) in the ITT population. A PP analysis is also performed. Missing values were replaced with a last-observation-carried-forward approach.
    Comparison groups
    Diet arm v Control Arm
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.49
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    10.07.2013-07.10.2016
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Diet Group
    Reporting group description
    		 -

    Reporting group title
    Control Group
    Reporting group description
    		 -

    Serious adverse events
    		 Diet Group Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Coronary artery disease
    Additional description: Progression coronary artery disease
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Ischemia
    Additional description: Cardiac Ischemia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Diet Group Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 40 (42.50%)
    9 / 40 (22.50%)
    Injury, poisoning and procedural complications
    Groin hematoma
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Lateral hematoma
    Additional description: Lateral hematoma next to puncture site of cardiac catheter
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Orthostatis dysregulation
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    1
    1
    Hypotension
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 40 (5.00%)
         occurrences all number
    1
    2
    Tachyarrhytmia absoluta
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Thoracic pain
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Hematoma
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Unclear pain
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Thoracic pain rear sternum
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Numbness in right arm
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Numbness in right middel finger
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Numbness in right thigh
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Numbness in right leg
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    1
    Sensivity disorder in right leg
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 40 (7.50%)
    2 / 40 (5.00%)
         occurrences all number
    3
    2
    Hypokaliemia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Hyperglycemia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Oct 2015
    Prolongation of study period because trial participations number was not reached in planned time.

    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.
    There are any limitiations and caveats during study period

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29535139
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