Infections related to ECMO-hospitalisation MedDRA version: 17.1 Level: PT Classification code 10022519 Term: Intensive care System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Meropenem
Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion
INN or Proposed INN: MEROPENEM
CAS Number: 96036-03-2
Other descriptive name: MEROPENEM
Concentr
Sponsors
Aarhus University Hospital, Skejby
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed informed consent - Age = 18 - In treatment with meropenem - Ongoing ECMO-treatment, =65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: - Allergy to meropenem - pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark
Contacts
Public ContactPelle Hanberg
Aarhus University Hospital
Outcome results
None listed