UZ Leuven
Leuven, 3000, Belgium
Location status: Recruiting
Location contact
Isabel Spriet, PharmD, PhD
CONTACT
Ruth Van Daele, PharmD
CONTACT
Recruiting
NCT Number: NCT04045366
Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients
This prospective study will explore the pharmacokinetic exposure and pharmacodynamics of the echinocandins (caspofungin or anidulafungin) in critically ill patients.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Treatment with anidulafungin or caspofungin
- Admitted to an ICU ward
Exclusion criteria
- < 18 years
- DNR 2 or 3
Treatment and study plan
Sample collection
OtherPlasma and BAL sample collection
Primary outcomes
-
Area under the curve (AUC)
Time frame: July 2020
The area under the concentration-time curve will be calculated
-
Half-life (T1/2)
Time frame: July 2020
The half-life will be calculated
-
Volume of distribution (Vd)
Time frame: July 2020
The volume of distribution will be calculated
-
Clearance (CL)
Time frame: July 2020
The clearance will be calculated
-
Maximum plasma concentration
Time frame: July 2020
The median maximum plasma concentration will be reported
-
Minimum plasma concentration
Time frame: July 2020
The median minimum plasma concentration will be reported
-
Average plasma concentration
Time frame: July 2020
The average plasma concentration will be calculated
Secondary outcomes
-
Influence of serum creatinin (mg/dL) on echinocandin-exposure
Time frame: July 2020
-
Influence of glomerular filtration rate (ml/min) on echinocandin-exposure
Time frame: July 2020
-
Influence of on bilirubin on echinocandin-exposure
Time frame: July 2020
-
Influence of gamma-GT on echinocandin-exposure
Time frame: July 2020
-
Influence of alkaline phosphatase on echinocandin-exposure
Time frame: July 2020
-
Influence of AST on echinocandin-exposure
Time frame: July 2020
-
Influence of ALT on echinocandin-exposure
Time frame: July 2020
-
Influence of SOFA ( sequential organ failure assessment) score on echinocandin-exposure
Time frame: July 2020
-
Influence of APACHE II (Acute Physiology and Chronic Health Evaluation II) score on echinocandin-exposure
Time frame: July 2020
-
Influence of total protein on echinocandin-exposure
Time frame: July 2020
-
Influence of serum albumin on echinocandin-exposure
Time frame: July 2020
-
Influence of Ang-1 on echinocandin-exposure
Time frame: July 2020
-
Influence of Ang-2 on echinocandin-exposure
Time frame: July 2020
-
Influence of VEGF on echinocandin-exposure
Time frame: July 2020
-
Influence of inflammation (CRP) on echinocandin-exposure
Time frame: July 2020
-
Influence of fluid balance (mL) on echinocandin-exposure
Time frame: July 2020
-
Influence of prothrombin time on echinocandin-exposure
Time frame: July 2020
Study contacts
Contact information is provided by the study sponsor or research team.
Isabel Spriet, PharmD, PhD
CONTACT
Ruth Van Daele, PharmD
CONTACT
Sponsors and collaborators
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Other
Collaborators
- KU Leuven
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Aug 5, 2019
- Registry last updated
- Jul 3, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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