Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients

Study Overview
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Brief Summary
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This prospective study will explore the pharmacokinetic exposure and pharmacodynamics of the echinocandins (caspofungin or anidulafungin) in critically ill patients.

Detailed Description
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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.

Official Title
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Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients

Conditions
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Critically Ill Patients

Intervention / Treatment
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* Other: Sample collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment with anidulafungin or caspofungin Admitted to an ICU ward Exclusion Criteria: < 18 years DNR 2 or 3

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Sample collection|Plasma and BAL sample collection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) | The area under the concentration-time curve will be calculated | July 2020 | 
| Half-life (T1/2) | The half-life will be calculated | July 2020 | 
| Volume of distribution (Vd) | The volume of distribution will be calculated | July 2020 | 
| Clearance (CL) | The clearance will be calculated | July 2020 | 
| Maximum plasma concentration | The median maximum plasma concentration will be reported | July 2020 | 
| Minimum plasma concentration | The median minimum plasma concentration will be reported | July 2020 | 
| Average plasma concentration | The average plasma concentration will be calculated | July 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Echinocandins, Critically ill patients