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

Recruiting

• Conditions: Critically Ill Patients

• Registration Number: NCT04045366
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2012-09-21
• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• < 18 years
• DNR 2 or 3

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Minimum plasma concentration	July 2020	The median minimum plasma concentration will be reported
Maximum plasma concentration	July 2020	The median maximum plasma concentration will be reported
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
Clearance (CL)	July 2020	The clearance will be calculated

Secondary Outcome Measures

Name	Time	Method
Influence of VEGF on echinocandin-exposure	July 2020
Influence of gamma-GT on echinocandin-exposure	July 2020
Influence of SOFA ( sequential organ failure assessment) score on echinocandin-exposure	July 2020
Influence of total protein on echinocandin-exposure	July 2020
Influence of serum creatinin (mg/dL) on echinocandin-exposure	July 2020
Influence of AST on echinocandin-exposure	July 2020
Influence of ALT 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 APACHE II (Acute Physiology and Chronic Health Evaluation II) score on echinocandin-exposure	July 2020
Influence of serum albumin on echinocandin-exposure	July 2020
Influence of fluid balance (mL) on echinocandin-exposure	July 2020
Influence of alkaline phosphatase 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 prothrombin time on echinocandin-exposure	July 2020
Influence of inflammation (CRP) on echinocandin-exposure	July 2020

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium