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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT04045366
Collaborator
KU Leuven (Other)
60
Enrollment
1
Location
99.3
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Impact of Capillary Leak and Hypoalbuminemia on PK/PD of Anidulafungin and Caspofungin in Critically Ill Patients
Actual Study Start Date :
Sep 21, 2012
Anticipated Primary Completion Date :
Jul 1, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Outcome Measures

Primary Outcome Measures

  1. Area under the curve (AUC) [July 2020]

    The area under the concentration-time curve will be calculated

  2. Half-life (T1/2) [July 2020]

    The half-life will be calculated

  3. Volume of distribution (Vd) [July 2020]

    The volume of distribution will be calculated

  4. Clearance (CL) [July 2020]

    The clearance will be calculated

  5. Maximum plasma concentration [July 2020]

    The median maximum plasma concentration will be reported

  6. Minimum plasma concentration [July 2020]

    The median minimum plasma concentration will be reported

  7. Average plasma concentration [July 2020]

    The average plasma concentration will be calculated

Secondary Outcome Measures

  1. Influence of serum creatinin (mg/dL) on echinocandin-exposure [July 2020]

  2. Influence of glomerular filtration rate (ml/min) on echinocandin-exposure [July 2020]

  3. Influence of on bilirubin on echinocandin-exposure [July 2020]

  4. Influence of gamma-GT on echinocandin-exposure [July 2020]

  5. Influence of alkaline phosphatase on echinocandin-exposure [July 2020]

  6. Influence of AST on echinocandin-exposure [July 2020]

  7. Influence of ALT on echinocandin-exposure [July 2020]

  8. Influence of SOFA ( sequential organ failure assessment) score on echinocandin-exposure [July 2020]

  9. Influence of APACHE II (Acute Physiology and Chronic Health Evaluation II) score on echinocandin-exposure [July 2020]

  10. Influence of total protein on echinocandin-exposure [July 2020]

  11. Influence of serum albumin on echinocandin-exposure [July 2020]

  12. Influence of Ang-1 on echinocandin-exposure [July 2020]

  13. Influence of Ang-2 on echinocandin-exposure [July 2020]

  14. Influence of VEGF on echinocandin-exposure [July 2020]

  15. Influence of inflammation (CRP) on echinocandin-exposure [July 2020]

  16. Influence of fluid balance (mL) on echinocandin-exposure [July 2020]

  17. Influence of prothrombin time on echinocandin-exposure [July 2020]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Treatment with anidulafungin or caspofungin

  • Admitted to an ICU ward

Exclusion Criteria:

  • < 18 years

  • DNR 2 or 3

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Leuven Leuven Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven
  • KU Leuven

Investigators

  • Principal Investigator: Isabel Spriet, PharmD, PhD, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT04045366
Other Study ID Numbers:
  • S54510
First Posted:
Aug 5, 2019
Last Update Posted:
Aug 5, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universitaire Ziekenhuizen Leuven
Pharmacokinetics
Echinocandins
Critically ill patients
Additional relevant MeSH terms:
Hypoalbuminemia
Critical Illness

Study Results

No Results Posted as of Aug 5, 2019