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.

Study Overview

• Status: Recruiting
• Conditions: Critically Ill Patients
• Intervention / Treatment: Other: Sample collection

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Isabel Spriet, PharmD, PhD; Phone Number: +32 16 34 30 80; Email: isabel.spriet@uzleuven.be
• Study Contact Backup: Name: Ruth Van Daele, PharmD; Phone Number: +32 16 34 30 80; Email: ruth.vandaele@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Isabel Spriet, PharmD, PhD; Phone Number: +32 16 34 30 80; Email: isabel.spriet@uzleuven.be
    • Contact: Ruth Van Daele, PharmD; Phone Number: +32 16 34 30 80; Email: ruth.vandaele@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Critically ill patients.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• < 18 years
• DNR 2 or 3

Study Plan

How is the study designed?

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven
• Investigators: Principal Investigator: Isabel Spriet, PharmD, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2012
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Critically ill patients; Echinocandins
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Hematologic Diseases; Blood Protein Disorders; Hypoproteinemia; Critical Illness; Hypoalbuminemia
• Other Study ID Numbers: S54510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No