Critically Ill Patients
Conditions
Keywords
Pharmacokinetics, Echinocandins, Critically ill patients
Brief summary
This prospective study will explore the pharmacokinetic exposure and pharmacodynamics of the echinocandins (caspofungin or anidulafungin) in critically ill patients.
Detailed description
This non-randomized, monocenter pharmacokinetic study will be carried out in critically ill patients receiving multiple dose treatment with echinocandins (caspofungin or anidulafungin). The pharmacokinetics and pharmacodynamics of the echinocandins in plasma and BAL will be determined. Especially, the relative contributions of two pathophysiological alterations (capillary leak and hypoalbuminemia) encountered in critically ill patients, will be explored. Also other correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.
Interventions
OTHERSample collection
Plasma and BAL sample collection
Sponsors
KU Leuven
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Treatment with anidulafungin or caspofungin * Admitted to an ICU ward
Exclusion criteria
* \< 18 years * DNR 2 or 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration | July 2020 | The median maximum plasma concentration will be reported |
| Minimum plasma concentration | July 2020 | The median minimum plasma concentration will be reported |
| Average plasma concentration | July 2020 | The average plasma concentration will be calculated |
| Volume of distribution (Vd) | July 2020 | The volume of distribution will be calculated |
| Clearance (CL) | July 2020 | The clearance will be calculated |
| Area under the curve (AUC) | July 2020 | The area under the concentration-time curve will be calculated |
| Half-life (T1/2) | July 2020 | The half-life will be calculated |
Secondary
| Measure | Time frame |
|---|---|
| Influence of alkaline phosphatase on echinocandin-exposure | July 2020 |
| Influence of AST on echinocandin-exposure | July 2020 |
| Influence of ALT on echinocandin-exposure | July 2020 |
| Influence of SOFA ( sequential organ failure assessment) score on echinocandin-exposure | July 2020 |
| Influence of APACHE II (Acute Physiology and Chronic Health Evaluation II) score on echinocandin-exposure | July 2020 |
| Influence of total protein on echinocandin-exposure | July 2020 |
| Influence of serum albumin on echinocandin-exposure | July 2020 |
| Influence of Ang-1 on echinocandin-exposure | July 2020 |
| Influence of Ang-2 on echinocandin-exposure | July 2020 |
| Influence of VEGF on echinocandin-exposure | July 2020 |
| Influence of inflammation (CRP) on echinocandin-exposure | July 2020 |
| Influence of fluid balance (mL) on echinocandin-exposure | July 2020 |
| Influence of prothrombin time on echinocandin-exposure | July 2020 |
| Influence of serum creatinin (mg/dL) on echinocandin-exposure | July 2020 |
| Influence of glomerular filtration rate (ml/min) on echinocandin-exposure | July 2020 |
| Influence of on bilirubin on echinocandin-exposure | July 2020 |
| Influence of gamma-GT on echinocandin-exposure | July 2020 |
Countries
Belgium
Contacts
Primary ContactIsabel Spriet, PharmD, PhD
Backup ContactRuth Van Daele, PharmD
Outcome results
None listed