Measurement of antabiotic concentration i subcutis and blood in patients receiving ECMO treatment
Phase 1
- Conditions
- Infections related to ECMO-hospitalisationMedDRA version: 17.1Level: PTClassification code 10022519Term: Intensive careSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2015-000218-23-DK
- Lead Sponsor
- Aarhus University Hospital, Skejby
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Signed informed consent
- Age = 18
- In treatment with meropenem
- Ongoing ECMO-treatment, <96 hours since start-up of ECMO-treatment
- Heavily sedated
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 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
Exclusion Criteria
- Allergy to meropenem
- pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective og this trial is to asses the penetration og meropenem into subcutis using the pharmacokinetic tool microdialysis. The primary endpoint is the time above the minimal inhibitory concentration (T>MIC). Secondary endpoints are standard pharmacokinetic parameters.;Secondary Objective: Not applicable;Primary end point(s): Time above the minimal inhibitory concentration (T>MIC) during a dosage interval (8 hours) in respectively 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): Secondary endpoints are standard pharmacokinetic parameters (eg. half-life, Cmax, AUC, Tmax and Vd);Timepoint(s) of evaluation of this end point: At the end of the study