0 Évaluations

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

Lien

https://clinicaltrials.gov/show/NCT01456013

Mots-clés

  1. 28/02/2016 28/02/2016 -
Téléchargé le

28 février 2016

DOI

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Licence

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
    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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0079399
    UMLS CUI [3]
    C0021430
    subject is scheduled to undergo an elective catheterization procedure
    Description

    Catheterization elective

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0007430
    UMLS CUI [1,2]
    C0439608
    hemodynamically stable
    Description

    hemodynamically stable

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0578150
    at increased risk of developing cin
    Description

    Contrast Induced Nephropathy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0748300
    subject has agreed to all follow-up testing.
    Description

    testing follow-up

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0039593
    UMLS CUI [1,2]
    C1522577
    Exclusion Criteria
    Description

    Exclusion Criteria

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

    congestive heart failure

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0018802
    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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0206074
    UMLS CUI [2]
    C0179804
    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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019993
    UMLS CUI [2]
    C0011946
    UMLS CUI [3]
    C0232804
    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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3806272
    UMLS CUI [2]
    C0003506
    currently has a known clinically significant electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
    Description

    Hemodynamics; electrolyte imbalance; Cardiac Arrhythmia

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019010
    UMLS CUI [2]
    C0342579
    UMLS CUI [3]
    C0003811
    patient has moderate to severe anemia (hematocrit < 27%) at screening
    Description

    severe anemia; Hematocrit level

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0238644
    UMLS CUI [2]
    C0518014
    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

    Type de données

    boolean

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

    heart attack

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0035229
    UMLS CUI [2]
    C0523807
    planned addition, discontinuation or dose adjustment of the nephrotoxic drugs
    Description

    dose adjustment; drug nephrotoxic

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2826232
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C1514118
    subject has a known hypersensitivity to furosemide and/or the contrast agent being used.
    Description

    hypersensitivity furosemide

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0016860
    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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    subject is pregnant or breastfeeding.
    Description

    lactating; pregnant

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2828358
    UMLS CUI [2]
    C0549206
    subject is unable to provide informed consent.
    Description

    informed consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430

    Similar models

    Eligibility Contrast Induced Nephropathy NCT01456013

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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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