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
Severe sepsis or septic shock
Beschreibung

Severe sepsis or septic shock

Datentyp

boolean

Alias
UMLS CUI [1]
C1719672
UMLS CUI [2]
C0036983
Onset of sepsis no longer than 12 hours
Beschreibung

Onset

Datentyp

boolean

Alias
UMLS CUI [1]
C0574845
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
UMLS CUI [1,2]
C0006840
Age ≥18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
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
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Pregnant or lactating women
Beschreibung

Gynaecological Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Ongoing invasive candida infection
Beschreibung

Ongoing invasive candida infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006840
UMLS CUI [1,2]
C0549178
Systemic antifungal therapy
Beschreibung

Antifungal therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0678026
Liver cirrhosis Child C
Beschreibung

Child Pugh Score

Datentyp

boolean

Alias
UMLS CUI [1]
C4055253
Cardiopulmonary bypass within the last 4 weeks
Beschreibung

Cardiopulmonary bypass

Datentyp

boolean

Alias
UMLS CUI [1]
C0007202
Treatment with immunoglobulins within the last 14 days
Beschreibung

Immunoglobulin Therapy

Datentyp

boolean

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

Immunosuppression

Datentyp

boolean

Alias
UMLS CUI [1]
C0021079
Participation in another intervention study
Beschreibung

Study Participation Status

Datentyp

boolean

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

Commitment

Datentyp

boolean

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

Prognosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0033325
Kin to or colleague of study personnel
Beschreibung

Relationship

Datentyp

boolean

Alias
UMLS CUI [1]
C0015608
Healthy Volunteers
Beschreibung

Control Group

Datentyp

boolean

Alias
UMLS CUI [1]
C0009932
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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])
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