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ID

23180

Beschrijving

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

Link

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

Trefwoorden

  1. 26-06-17 26-06-17 -
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26 juni 2017

DOI

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Licentie

Creative Commons BY 4.0

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    Eligibility Antibiotics in Critical Care Patients DRKS00004426 NCT01793012 DRKS00004426

    Eligibility Antibiotics in Critical Care Patients NCT01793012 DRKS00004426

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

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

    Age

    Datatype

    boolean

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

    Hospitalization: Critical Care Unit

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0019993
    UMLS CUI [1,2]
    C0021708
    2. Presence of infection by clinical assessment
    Beschrijving

    Infection

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    3. Treatment of the patients with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
    Beschrijving

    Antibiotics

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0003232
    4. Bolus administration of selected antibiotics
    Beschrijving

    Administration Route

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0013153
    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.
    Beschrijving

    Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    0. Healthy Volunteers
    Beschrijving

    Control Group

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009932
    1. Prophylactic antibiotics without clinical assessment for the presence of infection
    Beschrijving

    Prophylactic antibiotics

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1388076
    2. Planned shorter hospital stay than 4 days
    Beschrijving

    Hospital Stay

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3489408
    3. Administration of the selected antibiotic 14 days to 48 hours before the begin of the study
    Beschrijving

    Time of Administration

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1317775
    4. Only a single dose of an antibiotic per day
    Beschrijving

    Single Dose

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1960417
    5. Subsequent withdrawal of the participation in the study by the patient or the guardian
    Beschrijving

    Withdrawal

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2349954

    Similar models

    Eligibility Antibiotics in Critical Care Patients NCT01793012 DRKS00004426

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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