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ID

13684

Description

Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01456013

Link

https://clinicaltrials.gov/show/NCT01456013

Keywords

  1. 2/28/16 2/28/16 -
Uploaded on

February 28, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Contrast Induced Nephropathy NCT01456013

    Eligibility Contrast Induced Nephropathy NCT01456013

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    male or non-pregnant female equal or greater than the age of 18 years old and is able to provide informed consent.
    Description

    age; gender; informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    UMLS CUI [2]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [3]
    C0021430 (Informed Consent)
    subject is scheduled to undergo an elective catheterization procedure
    Description

    Catheterization elective

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007430 (Catheterization)
    SNOMED
    45211000
    LOINC
    LA11847-3
    UMLS CUI [1,2]
    C0439608 (elective)
    SNOMED
    103390000
    hemodynamically stable
    Description

    hemodynamically stable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0578150 (Hemodynamically stable)
    SNOMED
    301459008
    at increased risk of developing cin
    Description

    Contrast Induced Nephropathy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0748300 (RENAL FAILURE CHRONIC CONTRAST INDUCED)
    subject has agreed to all follow-up testing.
    Description

    testing follow-up

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0039593 (Testing)
    UMLS CUI [1,2]
    C1522577 (follow-up)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    class 3 or 4 congestive heart failure (chf)
    Description

    congestive heart failure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018802 (Congestive heart failure)
    SNOMED
    42343007
    LOINC
    MTHU020787
    is anuric or has undergone renal replacement therapy within the past month, or has a known inability to have a foley catheter placed.
    Description

    renal replacement therapy; foley catheter

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206074 (Renal Replacement Therapy)
    UMLS CUI [2]
    C0179804 (CATHETER, FOLEY)
    subject has been hospitalized or treated medically for any change in renal function over the past week (i.e. dialysis, etc.), or a significant change in renal function is noted at time of screening.
    Description

    hospitalization; dialysis; renal function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    UMLS CUI [2]
    C0011946 (Dialysis procedure)
    SNOMED
    108241001
    UMLS CUI [3]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    has documented severe aortic stenosis.(note: subjects who have undergone successful replacement or repair of their aortic valve are not excluded.)
    Description

    severe aortic stenosis; Replacement of aortic valve

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3806272 (Aortic stenosis, severe)
    UMLS CUI [2]
    C0003506 (Replacement of aortic valve (procedure))
    SNOMED
    26212005
    currently has a known clinically significant electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
    Description

    Hemodynamics; electrolyte imbalance; Cardiac Arrhythmia

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019010 (Hemodynamics)
    LOINC
    LP29712-4
    UMLS CUI [2]
    C0342579 (Electrolyte imbalance)
    SNOMED
    105593004
    LOINC
    MTHU052968
    UMLS CUI [3]
    C0003811 (Cardiac Arrhythmia)
    SNOMED
    698247007
    LOINC
    LA7414-1
    patient has moderate to severe anemia (hematocrit < 27%) at screening
    Description

    severe anemia; Hematocrit level

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0238644 (Anemia, severe)
    UMLS CUI [2]
    C0518014 (Hematocrit level)
    SNOMED
    365616005
    has received contrast within 10 days of procedure or has a planned additional cardiac or renal or other major surgical procedure within the7 day follow-up period.
    Description

    major surgical procedure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038894 (Surgery specialty)
    has ruled in for an serious heart attack within 48 hours of the planned procedure
    Description

    heart attack

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027051 (Myocardial Infarction)
    SNOMED
    22298006
    has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90% on room air assessed on day of procedure.
    Description

    respiratory insufficiency; Oxygen saturation measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0035229 (Respiratory Insufficiency)
    SNOMED
    409623005
    UMLS CUI [2]
    C0523807 (Oxygen saturation measurement)
    SNOMED
    104847001
    LOINC
    LP6432-1
    planned addition, discontinuation or dose adjustment of the nephrotoxic drugs
    Description

    dose adjustment; drug nephrotoxic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826232 (Dose Adjustment)
    UMLS CUI [2,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [2,2]
    C1514118 (Nephrotoxic)
    subject has a known hypersensitivity to furosemide and/or the contrast agent being used.
    Description

    hypersensitivity furosemide

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0016860 (furosemide)
    SNOMED
    81609008
    subject is currently, plans, or has been enrolled in another clinical study involving use of an investigational drug or device within the prior 30 days.
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    subject is pregnant or breastfeeding.
    Description

    lactating; pregnant

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2828358 (Lactating (finding))
    UMLS CUI [2]
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    subject is unable to provide informed consent.
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)

    Similar models

    Eligibility Contrast Induced Nephropathy NCT01456013

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age; gender; informed consent
    Item
    male or non-pregnant female equal or greater than the age of 18 years old and is able to provide informed consent.
    boolean
    C0001779 (UMLS CUI [1])
    C0079399 (UMLS CUI [2])
    C0021430 (UMLS CUI [3])
    Catheterization elective
    Item
    subject is scheduled to undergo an elective catheterization procedure
    boolean
    C0007430 (UMLS CUI [1,1])
    C0439608 (UMLS CUI [1,2])
    hemodynamically stable
    Item
    hemodynamically stable
    boolean
    C0578150 (UMLS CUI [1])
    Contrast Induced Nephropathy
    Item
    at increased risk of developing cin
    boolean
    C0748300 (UMLS CUI [1])
    testing follow-up
    Item
    subject has agreed to all follow-up testing.
    boolean
    C0039593 (UMLS CUI [1,1])
    C1522577 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    congestive heart failure
    Item
    class 3 or 4 congestive heart failure (chf)
    boolean
    C0018802 (UMLS CUI [1])
    renal replacement therapy; foley catheter
    Item
    is anuric or has undergone renal replacement therapy within the past month, or has a known inability to have a foley catheter placed.
    boolean
    C0206074 (UMLS CUI [1])
    C0179804 (UMLS CUI [2])
    hospitalization; dialysis; renal function
    Item
    subject has been hospitalized or treated medically for any change in renal function over the past week (i.e. dialysis, etc.), or a significant change in renal function is noted at time of screening.
    boolean
    C0019993 (UMLS CUI [1])
    C0011946 (UMLS CUI [2])
    C0232804 (UMLS CUI [3])
    severe aortic stenosis; Replacement of aortic valve
    Item
    has documented severe aortic stenosis.(note: subjects who have undergone successful replacement or repair of their aortic valve are not excluded.)
    boolean
    C3806272 (UMLS CUI [1])
    C0003506 (UMLS CUI [2])
    Hemodynamics; electrolyte imbalance; Cardiac Arrhythmia
    Item
    currently has a known clinically significant electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
    boolean
    C0019010 (UMLS CUI [1])
    C0342579 (UMLS CUI [2])
    C0003811 (UMLS CUI [3])
    severe anemia; Hematocrit level
    Item
    patient has moderate to severe anemia (hematocrit < 27%) at screening
    boolean
    C0238644 (UMLS CUI [1])
    C0518014 (UMLS CUI [2])
    major surgical procedure
    Item
    has received contrast within 10 days of procedure or has a planned additional cardiac or renal or other major surgical procedure within the7 day follow-up period.
    boolean
    C0038894 (UMLS CUI [1])
    heart attack
    Item
    has ruled in for an serious heart attack within 48 hours of the planned procedure
    boolean
    C0027051 (UMLS CUI [1])
    respiratory insufficiency; Oxygen saturation measurement
    Item
    has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90% on room air assessed on day of procedure.
    boolean
    C0035229 (UMLS CUI [1])
    C0523807 (UMLS CUI [2])
    dose adjustment; drug nephrotoxic
    Item
    planned addition, discontinuation or dose adjustment of the nephrotoxic drugs
    boolean
    C2826232 (UMLS CUI [1])
    C0013227 (UMLS CUI [2,1])
    C1514118 (UMLS CUI [2,2])
    hypersensitivity furosemide
    Item
    subject has a known hypersensitivity to furosemide and/or the contrast agent being used.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0016860 (UMLS CUI [1,2])
    Study Subject Participation Status
    Item
    subject is currently, plans, or has been enrolled in another clinical study involving use of an investigational drug or device within the prior 30 days.
    boolean
    C2348568 (UMLS CUI [1])
    lactating; pregnant
    Item
    subject is pregnant or breastfeeding.
    boolean
    C2828358 (UMLS CUI [1])
    C0549206 (UMLS CUI [2])
    informed consent
    Item
    subject is unable to provide informed consent.
    boolean
    C0021430 (UMLS CUI [1])

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