ID

23180

Descrição

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

Palavras-chave

Versões (1)
  1. 26/06/2017 26/06/2017 -
Transferido a

26 de junho de 2017

DOI

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Licença

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
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
UMLS CUI [1,2]
C0021708
2. Presence of infection by clinical assessment
Descrição

Infection

Tipo de dados

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
Descrição

Antibiotics

Tipo de dados

boolean

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

Administration Route

Tipo de dados

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.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Descrição

Control Group

Tipo de dados

boolean

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

Prophylactic antibiotics

Tipo de dados

boolean

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

Hospital Stay

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3489408
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
4. Only a single dose of an antibiotic per day
Descrição

Single Dose

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1960417
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
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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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