ID

23180

Beskrivning

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

Länk

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

Nyckelord

Versioner (1)
  1. 2017-06-26 2017-06-26 -
Uppladdad den

26 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Antibiotics in Critical Care Patients DRKS00004426 NCT01793012 DRKS00004426

Engelsk

Eligibility Antibiotics in Critical Care Patients NCT01793012 DRKS00004426

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

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

Hospitalization: Critical Care Unit

Datatyp

boolean

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

Infection

Datatyp

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
Beskrivning

Antibiotics

Datatyp

boolean

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

Administration Route

Datatyp

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.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Beskrivning

Control Group

Datatyp

boolean

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

Prophylactic antibiotics

Datatyp

boolean

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

Hospital Stay

Datatyp

boolean

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

Time of Administration

Datatyp

boolean

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

Single Dose

Datatyp

boolean

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

Withdrawal

Datatyp

boolean

Alias
UMLS CUI [1]
C2349954
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Similar models

Eligibility Antibiotics in Critical Care Patients NCT01793012 DRKS00004426

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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