ID

23644

Description

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

Keywords

Versions (1)
  1. 7/10/17 7/10/17 -
Uploaded on

July 10, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Sepsis NCT02734550 DRKS00010285

English

Eligibility Sepsis NCT02734550 DRKS00010285

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Severe sepsis or septic shock
Description

Severe sepsis or septic shock

Data type

boolean

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

Onset

Data type

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
Description

Risk of invasive candida infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0006840
Age ≥18 years
Description

Age

Data type

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.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Pregnant or lactating women
Description

Gynaecological Status

Data type

boolean

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

Ongoing invasive candida infection

Data type

boolean

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

Antifungal therapy

Data type

boolean

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

Child Pugh Score

Data type

boolean

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

Cardiopulmonary bypass

Data type

boolean

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

Immunoglobulin Therapy

Data type

boolean

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

Immunosuppression

Data type

boolean

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

Study Participation Status

Data type

boolean

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

Commitment

Data type

boolean

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

Prognosis

Data type

boolean

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

Relationship

Data type

boolean

Alias
UMLS CUI [1]
C0015608
Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
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Similar models

Eligibility Sepsis NCT02734550 DRKS00010285

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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