measurement of antibiotica concentration in blood and subcutis in patients treated with crrt
Phase 1
- Conditions
- infections reloated to CRRTMedDRA version: 20.0Level: LLTClassification code 10021804Term: Infection bacterialSystem Organ Class: 100000019640MedDRA version: 20.0Level: LLTClassification code 10021863Term: Infection respiratorySystem Organ Class: 100000015677MedDRA version: 20.0Level: LLTClassification code 10021867Term: Infection systemicSystem Organ Class: 100000165071Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2017-000717-24-DK
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
informed consent
age>18
piperacillin treatment
CRRT
sedation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
pregancy
lack of consent
allergy to piperacillin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to measure concentration of piperacillin/tazobactam in subcutisw and blood in patients on crrt;Secondary Objective: na;Primary end point(s): time above MIC during dosage interval in plasma and subcutis;Timepoint(s) of evaluation of this end point: at the end of the study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): pharmacokinetics ( Cmax, Tmax, Vd);Timepoint(s) of evaluation of this end point: at the end of the study