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ID

23644

Beschreibung

Responsible Party: Center for Sepsis Control and Care, Germany ClinicalTrials.gov Identifier: NCT02734550 History of Changes Other Study ID Numbers: ZKSJ0087 01EO1502 ( Other Grant/Funding Number: Federal Ministry of Education and Research of Germany ) U1111-1181-8724 ( Registry Identifier: Universal Trial Number ) DRKS00010285 ( Registry Identifier: German Clinical Trial Register ) Study First Received: April 6, 2016 Last Updated: January 27, 2017 (1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection in Sepsis (CandiSep) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02734550

Link

https://clinicaltrials.gov/ct2/show/NCT02734550

Stichworte

Versionen (1)
  1. 10.07.17 10.07.17 -
Hochgeladen am

10. Juli 2017

DOI

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    Eligibility Sepsis NCT02734550 DRKS00010285

    Englisch

    Eligibility Sepsis NCT02734550 DRKS00010285

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693 (Inclusion)
    Severe sepsis or septic shock
    Beschreibung

    Severe sepsis or septic shock

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1719672 (Severe Sepsis)
    UMLS CUI [2]
    C0036983 (Septic Shock)
    SNOMED
    76571007
    Onset of sepsis no longer than 12 hours
    Beschreibung

    Onset

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0574845 (Date of onset)
    SNOMED
    298059007
    LOINC
    MTHU048807
    Increased risk of invasive candida infection with at least one of the following criteria: - total parenteral nutrition ≥48 hours - abdominal surgery within the last 7 days - antimicrobial therapy for at least 48 hours within the last 7 days - Acute or chronic renal failure with renal replacement therapy
    Beschreibung

    Risk of invasive candida infection

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0035647 (Risk)
    SNOMED
    30207005
    UMLS CUI [1,2]
    C0006840 (Candidiasis)
    SNOMED
    78048006
    Age ≥18 years
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    Informed consent of the patient or legal representative or delayed consent process is started if patient is incapable of giving informed consent and no legal representative is available.
    Beschreibung

    Informed Consent

    Datentyp

    boolean

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

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251 (Exclusion Criteria)
    Pregnant or lactating women
    Beschreibung

    Gynaecological Status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    Ongoing invasive candida infection
    Beschreibung

    Ongoing invasive candida infection

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0006840 (Candidiasis)
    SNOMED
    78048006
    UMLS CUI [1,2]
    C0549178 (Continuous)
    SNOMED
    255238004
    LOINC
    LA16902-1
    Systemic antifungal therapy
    Beschreibung

    Antifungal therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0678026 (Antifungal therapy)
    SNOMED
    718526003
    Liver cirrhosis Child C
    Beschreibung

    Child Pugh Score

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C4055253 (Child-Pugh - Total Score)
    Cardiopulmonary bypass within the last 4 weeks
    Beschreibung

    Cardiopulmonary bypass

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0007202 (Cardiopulmonary Bypass)
    SNOMED
    63697000
    Treatment with immunoglobulins within the last 14 days
    Beschreibung

    Immunoglobulin Therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021022 (Immunoglobulin Therapy)
    Immunosuppression (solid organ transplantation, AISA, leukopenia)
    Beschreibung

    Immunosuppression

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021079 (Therapeutic immunosuppression)
    SNOMED
    86553008
    Participation in another intervention study
    Beschreibung

    Study Participation Status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    No commitment to full therapy (i.e. DNR order)
    Beschreibung

    Commitment

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0870312 (commitment)
    Unfavourable prognosis due to secondary diseases
    Beschreibung

    Prognosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0033325 (Forecast of outcome)
    SNOMED
    20481000
    LOINC
    MTHU048144
    Kin to or colleague of study personnel
    Beschreibung

    Relationship

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0015608 (Family Relationship)
    LOINC
    LA16499-8
    Healthy Volunteers
    Beschreibung

    Control Group

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009932 (Control Groups)
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Sepsis NCT02734550 DRKS00010285

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Severe sepsis or septic shock
    Item
    Severe sepsis or septic shock
    boolean
    C1719672 (UMLS CUI [1])
    C0036983 (UMLS CUI [2])
    Onset
    Item
    Onset of sepsis no longer than 12 hours
    boolean
    C0574845 (UMLS CUI [1])
    Risk of invasive candida infection
    Item
    Increased risk of invasive candida infection with at least one of the following criteria: - total parenteral nutrition ≥48 hours - abdominal surgery within the last 7 days - antimicrobial therapy for at least 48 hours within the last 7 days - Acute or chronic renal failure with renal replacement therapy
    boolean
    C0035647 (UMLS CUI [1,1])
    C0006840 (UMLS CUI [1,2])
    Age
    Item
    Age ≥18 years
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent
    Item
    Informed consent of the patient or legal representative or delayed consent process is started if patient is incapable of giving informed consent and no legal representative is available.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Gynaecological Status
    Item
    Pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Ongoing invasive candida infection
    Item
    Ongoing invasive candida infection
    boolean
    C0006840 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Antifungal therapy
    Item
    Systemic antifungal therapy
    boolean
    C0678026 (UMLS CUI [1])
    Child Pugh Score
    Item
    Liver cirrhosis Child C
    boolean
    C4055253 (UMLS CUI [1])
    Cardiopulmonary bypass
    Item
    Cardiopulmonary bypass within the last 4 weeks
    boolean
    C0007202 (UMLS CUI [1])
    Immunoglobulin Therapy
    Item
    Treatment with immunoglobulins within the last 14 days
    boolean
    C0021022 (UMLS CUI [1])
    Immunosuppression
    Item
    Immunosuppression (solid organ transplantation, AISA, leukopenia)
    boolean
    C0021079 (UMLS CUI [1])
    Study Participation Status
    Item
    Participation in another intervention study
    boolean
    C2348568 (UMLS CUI [1])
    Commitment
    Item
    No commitment to full therapy (i.e. DNR order)
    boolean
    C0870312 (UMLS CUI [1])
    Prognosis
    Item
    Unfavourable prognosis due to secondary diseases
    boolean
    C0033325 (UMLS CUI [1])
    Relationship
    Item
    Kin to or colleague of study personnel
    boolean
    C0015608 (UMLS CUI [1])
    Control Group
    Item
    Healthy Volunteers
    boolean
    C0009932 (UMLS CUI [1])
    Zum Seitenanfang zurückkehren 

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