0 Avaliações
ID

16869

Descrição

Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA; ODM derived from: https://clinicaltrials.gov/show/NCT00653042

Link

https://clinicaltrials.gov/show/NCT00653042

Palavras-chave

Versões (1)
  1. 11/08/2016 11/08/2016 -
Transferido a

11 de agosto de 2016

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Coronary Artery Bypass Surgery NCT00653042

    Inglês

    Eligibility Coronary Artery Bypass Surgery NCT00653042

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    nyha class ii-iv chf
    Descrição

    Congestive heart failure | New York Heart Association Classification

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0018802
    UMLS CUI [2]
    C1275491
    presenting for cabg with or without mitral valve repair or replacement procedure
    Descrição

    Coronary Artery Bypass Surgery | Mitral Valve: Repair | Replacement of mitral valve

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0010055
    UMLS CUI [2]
    C0869755
    UMLS CUI [3]
    C0026268
    planned utilization of cpb
    Descrição

    Cardiopulmonary Bypass Planned

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0007202
    UMLS CUI [1,2]
    C1301732
    documentation of left ventricular ejection fraction (lvef) less than or equal to 40% measured by nuclear scan, echocardiogram (echo), or ventriculogram, within 90 days prior to surgery.
    Descrição

    Left ventricular ejection fraction | Radionuclide Imaging | Echocardiogram | Ventriculogram | Operative Surgical Procedures

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    UMLS CUI [2]
    C0034606
    UMLS CUI [3]
    C2243117
    UMLS CUI [4]
    C0394239
    UMLS CUI [5]
    C0543467
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    planned aortic valve replacement or repair
    Descrição

    Replacement of aortic valve Planned | Aortic Valve: Repair Planned

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0003506
    UMLS CUI [1,2]
    C1301732
    UMLS CUI [2,1]
    C0869750
    UMLS CUI [2,2]
    C1301732
    ongoing or chronic dialysis (either hemodialysis or continuous ambulatory peritoneal dialysis)
    Descrição

    Dialysis | dialysis chronic | Hemodialysis | Peritoneal Dialysis, Continuous Ambulatory

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0011946
    UMLS CUI [2]
    C0743165
    UMLS CUI [3]
    C0019004
    UMLS CUI [4]
    C0031140
    restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return
    Descrição

    Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy | Pericarditis, Constrictive | Cardiac Tamponade

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0007196
    UMLS CUI [2]
    C0007194
    UMLS CUI [3]
    C0031048
    UMLS CUI [4]
    C0007177
    documented or suspected low cardiac filling pressures
    Descrição

    Intracardiac pressure low

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0428876
    UMLS CUI [1,2]
    C0205251
    any known congenital heart disease
    Descrição

    Congenital heart disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0152021
    known allergic reaction or sensitivity to nesiritide or excipients
    Descrição

    Allergic Reaction Nesiritide | Allergic Reaction Nesiritide Excipient | Hypersensitivity Nesiritide | Hypersensitivity Nesiritide Excipient

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304
    UMLS CUI [1,2]
    C0054015
    UMLS CUI [2,1]
    C1527304
    UMLS CUI [2,2]
    C0054015
    UMLS CUI [2,3]
    C0015237
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0054015
    UMLS CUI [4,1]
    C0020517
    UMLS CUI [4,2]
    C0054015
    UMLS CUI [4,3]
    C0015237
    females of childbearing potential with a positive serum pregnancy test, and nursing mothers
    Descrição

    Childbearing Potential Serum pregnancy test positive | Breast Feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0430063
    UMLS CUI [2]
    C0006147
    treated with investigational drug or device within last 30 days
    Descrição

    Investigational New Drugs | Investigational Medical Device

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    UMLS CUI [2]
    C2346570
    documented fever (>101 degrees f) within 72 hours of surgery
    Descrição

    Fever Degrees fahrenheit | Operative Surgical Procedures

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0015967
    UMLS CUI [1,2]
    C0456628
    UMLS CUI [2]
    C0543467
    wbc > 15,000/mm3 within 72 hours of surgery
    Descrição

    White Blood Cell Count procedure | Operative Surgical Procedures

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    UMLS CUI [2]
    C0543467
    documented bacterial/fungal/viral infection requiring administration of iv antibiotics within 7 days before surgery
    Descrição

    Bacterial Infections Requirement Intravenous antibiotic therapy | Mycoses Requirement Intravenous antibiotic therapy | Virus Diseases Requirement Intravenous antibiotic therapy | Operative Surgical Procedures

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0004623
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0559680
    UMLS CUI [2,1]
    C0026946
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C0559680
    UMLS CUI [3,1]
    C0042769
    UMLS CUI [3,2]
    C1514873
    UMLS CUI [3,3]
    C0559680
    UMLS CUI [4]
    C0543467
    pulmonary disease (copd, asthma or other condition) that required inpatient medical or surgical treatment within 60 days before surgery. treatment exclusion criteria (obtained after anesthesia induction and before chest incision prior to the start of study drug) include: mean pulmonary artery pressure consistently < or equal to 15mmhg
    Descrição

    Lung diseases | Chronic Obstructive Airway Disease | Asthma | Hospitalization Patient need for | Operative Surgical Procedures Patient need for | Induction of anesthesia | Thoracotomy | Investigational New Drugs | Pulmonary artery mean pressure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0024115
    UMLS CUI [2]
    C0024117
    UMLS CUI [3]
    C0004096
    UMLS CUI [4,1]
    C0019993
    UMLS CUI [4,2]
    C0686904
    UMLS CUI [5,1]
    C0543467
    UMLS CUI [5,2]
    C0686904
    UMLS CUI [6]
    C0853212
    UMLS CUI [7]
    C0039991
    UMLS CUI [8]
    C0013230
    UMLS CUI [9]
    C0428645
    central venous pressure consistently < 6 mmhg
    Descrição

    Measurement of central venous pressure

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0199666
    and systolic blood pressure consistently < 90 mmhg. use of open-label nesiritide within 48 hours of study drug administration.
    Descrição

    Systolic Pressure | Nesiritide | Investigational New Drugs

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0871470
    UMLS CUI [2]
    C0054015
    UMLS CUI [3]
    C0013230
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    Eligibility Coronary Artery Bypass Surgery NCT00653042

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Congestive heart failure | New York Heart Association Classification
    Item
    nyha class ii-iv chf
    boolean
    C0018802 (UMLS CUI [1])
    C1275491 (UMLS CUI [2])
    Coronary Artery Bypass Surgery | Mitral Valve: Repair | Replacement of mitral valve
    Item
    presenting for cabg with or without mitral valve repair or replacement procedure
    boolean
    C0010055 (UMLS CUI [1])
    C0869755 (UMLS CUI [2])
    C0026268 (UMLS CUI [3])
    Cardiopulmonary Bypass Planned
    Item
    planned utilization of cpb
    boolean
    C0007202 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Left ventricular ejection fraction | Radionuclide Imaging | Echocardiogram | Ventriculogram | Operative Surgical Procedures
    Item
    documentation of left ventricular ejection fraction (lvef) less than or equal to 40% measured by nuclear scan, echocardiogram (echo), or ventriculogram, within 90 days prior to surgery.
    boolean
    C0428772 (UMLS CUI [1])
    C0034606 (UMLS CUI [2])
    C2243117 (UMLS CUI [3])
    C0394239 (UMLS CUI [4])
    C0543467 (UMLS CUI [5])
    Item Group
    C0680251 (UMLS CUI)
    Replacement of aortic valve Planned | Aortic Valve: Repair Planned
    Item
    planned aortic valve replacement or repair
    boolean
    C0003506 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    C0869750 (UMLS CUI [2,1])
    C1301732 (UMLS CUI [2,2])
    Dialysis | dialysis chronic | Hemodialysis | Peritoneal Dialysis, Continuous Ambulatory
    Item
    ongoing or chronic dialysis (either hemodialysis or continuous ambulatory peritoneal dialysis)
    boolean
    C0011946 (UMLS CUI [1])
    C0743165 (UMLS CUI [2])
    C0019004 (UMLS CUI [3])
    C0031140 (UMLS CUI [4])
    Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy | Pericarditis, Constrictive | Cardiac Tamponade
    Item
    restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return
    boolean
    C0007196 (UMLS CUI [1])
    C0007194 (UMLS CUI [2])
    C0031048 (UMLS CUI [3])
    C0007177 (UMLS CUI [4])
    Intracardiac pressure low
    Item
    documented or suspected low cardiac filling pressures
    boolean
    C0428876 (UMLS CUI [1,1])
    C0205251 (UMLS CUI [1,2])
    Congenital heart disease
    Item
    any known congenital heart disease
    boolean
    C0152021 (UMLS CUI [1])
    Allergic Reaction Nesiritide | Allergic Reaction Nesiritide Excipient | Hypersensitivity Nesiritide | Hypersensitivity Nesiritide Excipient
    Item
    known allergic reaction or sensitivity to nesiritide or excipients
    boolean
    C1527304 (UMLS CUI [1,1])
    C0054015 (UMLS CUI [1,2])
    C1527304 (UMLS CUI [2,1])
    C0054015 (UMLS CUI [2,2])
    C0015237 (UMLS CUI [2,3])
    C0020517 (UMLS CUI [3,1])
    C0054015 (UMLS CUI [3,2])
    C0020517 (UMLS CUI [4,1])
    C0054015 (UMLS CUI [4,2])
    C0015237 (UMLS CUI [4,3])
    Childbearing Potential Serum pregnancy test positive | Breast Feeding
    Item
    females of childbearing potential with a positive serum pregnancy test, and nursing mothers
    boolean
    C3831118 (UMLS CUI [1,1])
    C0430063 (UMLS CUI [1,2])
    C0006147 (UMLS CUI [2])
    Investigational New Drugs | Investigational Medical Device
    Item
    treated with investigational drug or device within last 30 days
    boolean
    C0013230 (UMLS CUI [1])
    C2346570 (UMLS CUI [2])
    Fever Degrees fahrenheit | Operative Surgical Procedures
    Item
    documented fever (>101 degrees f) within 72 hours of surgery
    boolean
    C0015967 (UMLS CUI [1,1])
    C0456628 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [2])
    White Blood Cell Count procedure | Operative Surgical Procedures
    Item
    wbc > 15,000/mm3 within 72 hours of surgery
    boolean
    C0023508 (UMLS CUI [1])
    C0543467 (UMLS CUI [2])
    Bacterial Infections Requirement Intravenous antibiotic therapy | Mycoses Requirement Intravenous antibiotic therapy | Virus Diseases Requirement Intravenous antibiotic therapy | Operative Surgical Procedures
    Item
    documented bacterial/fungal/viral infection requiring administration of iv antibiotics within 7 days before surgery
    boolean
    C0004623 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0559680 (UMLS CUI [1,3])
    C0026946 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0559680 (UMLS CUI [2,3])
    C0042769 (UMLS CUI [3,1])
    C1514873 (UMLS CUI [3,2])
    C0559680 (UMLS CUI [3,3])
    C0543467 (UMLS CUI [4])
    Lung diseases | Chronic Obstructive Airway Disease | Asthma | Hospitalization Patient need for | Operative Surgical Procedures Patient need for | Induction of anesthesia | Thoracotomy | Investigational New Drugs | Pulmonary artery mean pressure
    Item
    pulmonary disease (copd, asthma or other condition) that required inpatient medical or surgical treatment within 60 days before surgery. treatment exclusion criteria (obtained after anesthesia induction and before chest incision prior to the start of study drug) include: mean pulmonary artery pressure consistently < or equal to 15mmhg
    boolean
    C0024115 (UMLS CUI [1])
    C0024117 (UMLS CUI [2])
    C0004096 (UMLS CUI [3])
    C0019993 (UMLS CUI [4,1])
    C0686904 (UMLS CUI [4,2])
    C0543467 (UMLS CUI [5,1])
    C0686904 (UMLS CUI [5,2])
    C0853212 (UMLS CUI [6])
    C0039991 (UMLS CUI [7])
    C0013230 (UMLS CUI [8])
    C0428645 (UMLS CUI [9])
    Measurement of central venous pressure
    Item
    central venous pressure consistently < 6 mmhg
    boolean
    C0199666 (UMLS CUI [1])
    Systolic Pressure | Nesiritide | Investigational New Drugs
    Item
    and systolic blood pressure consistently < 90 mmhg. use of open-label nesiritide within 48 hours of study drug administration.
    boolean
    C0871470 (UMLS CUI [1])
    C0054015 (UMLS CUI [2])
    C0013230 (UMLS CUI [3])
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