Clinical trial NCT04045366: Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients
Official title: Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critically Ill Patients
Keywords: Pharmacokinetics
Echinocandins
Critically ill patients
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2019-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Eligibility criteria: Inclusion Criteria:

* Treatment with anidulafungin or caspofungin
* Admitted to an ICU ward

Exclusion Criteria:

* \< 18 years
* DNR 2 or 3

Primary outcomes:
measure: Area under the curve (AUC)
timeFrame: July 2020
measure: Half-life (T1/2)
timeFrame: July 2020
measure: Volume of distribution (Vd)
timeFrame: July 2020
measure: Clearance (CL)
timeFrame: July 2020
measure: Maximum plasma concentration
timeFrame: July 2020
measure: Minimum plasma concentration
timeFrame: July 2020
measure: Average plasma concentration
timeFrame: July 2020
Secondary outcomes:
measure: Influence of serum creatinin (mg/dL) on echinocandin-exposure
timeFrame: July 2020
measure: Influence of glomerular filtration rate (ml/min) on echinocandin-exposure
timeFrame: July 2020
measure: Influence of on bilirubin on echinocandin-exposure
timeFrame: July 2020
measure: Influence of gamma-GT on echinocandin-exposure
timeFrame: July 2020
measure: Influence of alkaline phosphatase on echinocandin-exposure
timeFrame: July 2020
measure: Influence of AST on echinocandin-exposure
timeFrame: July 2020
measure: Influence of ALT on echinocandin-exposure
timeFrame: July 2020
measure: Influence of SOFA ( sequential organ failure assessment) score on echinocandin-exposure
timeFrame: July 2020
measure: Influence of APACHE II (Acute Physiology and Chronic Health Evaluation II) score on echinocandin-exposure
timeFrame: July 2020
measure: Influence of total protein on echinocandin-exposure
timeFrame: July 2020
measure: Influence of serum albumin on echinocandin-exposure
timeFrame: July 2020
measure: Influence of Ang-1 on echinocandin-exposure
timeFrame: July 2020
measure: Influence of Ang-2 on echinocandin-exposure
timeFrame: July 2020
measure: Influence of VEGF on echinocandin-exposure
timeFrame: July 2020
measure: Influence of inflammation (CRP) on echinocandin-exposure
timeFrame: July 2020
measure: Influence of fluid balance (mL) on echinocandin-exposure
timeFrame: July 2020
measure: Influence of prothrombin time on echinocandin-exposure
timeFrame: July 2020
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Isabel Spriet, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: