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23180

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Responsible Party: Michael Zoller MD, senior physician, Ludwig-Maximilians - University of Munich ClinicalTrials.gov Identifier: NCT01793012 History of Changes Other Study ID Numbers: MUC 428-12 DRKS00004426 ( Other Identifier: German clinical trials register ) Study First Received: January 24, 2013 Last Updated: March 30, 2015 Drug Monitoring of Antibiotics in Critical Care Patients (DRAK) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01793012

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https://clinicaltrials.gov/ct2/show/NCT01793012

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  1. 26/06/17 26/06/17 -
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26 giugno 2017

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Creative Commons BY 4.0
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    Eligibility Antibiotics in Critical Care Patients DRKS00004426 NCT01793012 DRKS00004426

    Inglês

    Eligibility Antibiotics in Critical Care Patients NCT01793012 DRKS00004426

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693 (Inclusion)
    0. 18 Years and older (Adult, Senior)
    Descrição

    Age

    Tipo de dados

    boolean

    1. Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich
    Descrição

    Hospitalization: Critical Care Unit

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0019993 (Hospitalization)
    SNOMED
    394656005
    LOINC
    LA15417-1
    UMLS CUI [1,2]
    C0021708 (intensive care unit)
    SNOMED
    309904001
    2. Presence of infection by clinical assessment
    Descrição

    Infection

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    3. Treatment of the patients with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
    Descrição

    Antibiotics

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0003232 (Antibiotics)
    SNOMED
    255631004
    LOINC
    LP31426-7
    4. Bolus administration of selected antibiotics
    Descrição

    Administration Route

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    5. Valid informed consent subscribed by the patient or by his or her legal guardian or - if only a provisional guardian is defined - by the provisional guardian.
    Descrição

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251 (Exclusion Criteria)
    0. Healthy Volunteers
    Descrição

    Control Group

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0009932 (Control Groups)
    1. Prophylactic antibiotics without clinical assessment for the presence of infection
    Descrição

    Prophylactic antibiotics

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1388076 (antibiotics; administration, prophylactic)
    2. Planned shorter hospital stay than 4 days
    Descrição

    Hospital Stay

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3489408 (Hospital Stay)
    3. Administration of the selected antibiotic 14 days to 48 hours before the begin of the study
    Descrição

    Time of Administration

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1317775 (Time administration started)
    LOINC
    MTHU016127
    4. Only a single dose of an antibiotic per day
    Descrição

    Single Dose

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1960417 (Single dose characteristic)
    SNOMED
    426146003
    5. Subsequent withdrawal of the participation in the study by the patient or the guardian
    Descrição

    Withdrawal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2349954 (Withdraw (activity))
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    Similar models

    Eligibility Antibiotics in Critical Care Patients NCT01793012 DRKS00004426

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Age
    Item
    0. 18 Years and older (Adult, Senior)
    boolean
    Hospitalization: Critical Care Unit
    Item
    1. Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich
    boolean
    C0019993 (UMLS CUI [1,1])
    C0021708 (UMLS CUI [1,2])
    Infection
    Item
    2. Presence of infection by clinical assessment
    boolean
    C0009450 (UMLS CUI [1])
    Antibiotics
    Item
    3. Treatment of the patients with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
    boolean
    C0003232 (UMLS CUI [1])
    Administration Route
    Item
    4. Bolus administration of selected antibiotics
    boolean
    C0013153 (UMLS CUI [1])
    Informed Consent
    Item
    5. Valid informed consent subscribed by the patient or by his or her legal guardian or - if only a provisional guardian is defined - by the provisional guardian.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Control Group
    Item
    0. Healthy Volunteers
    boolean
    C0009932 (UMLS CUI [1])
    Prophylactic antibiotics
    Item
    1. Prophylactic antibiotics without clinical assessment for the presence of infection
    boolean
    C1388076 (UMLS CUI [1])
    Hospital Stay
    Item
    2. Planned shorter hospital stay than 4 days
    boolean
    C3489408 (UMLS CUI [1])
    Time of Administration
    Item
    3. Administration of the selected antibiotic 14 days to 48 hours before the begin of the study
    boolean
    C1317775 (UMLS CUI [1])
    Single Dose
    Item
    4. Only a single dose of an antibiotic per day
    boolean
    C1960417 (UMLS CUI [1])
    Withdrawal
    Item
    5. Subsequent withdrawal of the participation in the study by the patient or the guardian
    boolean
    C2349954 (UMLS CUI [1])
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