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

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ClinicalTrials.gov Identifier: NCT04045366
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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
Critically Ill Patients 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.

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Study Type : Observational
Estimated 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 : September 21, 2012
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 31, 2020

Intervention Details:
  • Other: Sample collection
    Plasma and BAL sample collection


Primary Outcome Measures :
  1. Area under the curve (AUC) [ Time Frame: July 2020 ]
    The area under the concentration-time curve will be calculated

  2. Half-life (T1/2) [ Time Frame: July 2020 ]
    The half-life will be calculated

  3. Volume of distribution (Vd) [ Time Frame: July 2020 ]
    The volume of distribution will be calculated

  4. Clearance (CL) [ Time Frame: July 2020 ]
    The clearance will be calculated

  5. Maximum plasma concentration [ Time Frame: July 2020 ]
    The median maximum plasma concentration will be reported

  6. Minimum plasma concentration [ Time Frame: July 2020 ]
    The median minimum plasma concentration will be reported

  7. Average plasma concentration [ Time Frame: July 2020 ]
    The average plasma concentration will be calculated


Secondary Outcome Measures :
  1. Influence of serum creatinin (mg/dL) on echinocandin-exposure [ Time Frame: July 2020 ]
  2. Influence of glomerular filtration rate (ml/min) on echinocandin-exposure [ Time Frame: July 2020 ]
  3. Influence of on bilirubin on echinocandin-exposure [ Time Frame: July 2020 ]
  4. Influence of gamma-GT on echinocandin-exposure [ Time Frame: July 2020 ]
  5. Influence of alkaline phosphatase on echinocandin-exposure [ Time Frame: July 2020 ]
  6. Influence of AST on echinocandin-exposure [ Time Frame: July 2020 ]
  7. Influence of ALT on echinocandin-exposure [ Time Frame: July 2020 ]
  8. Influence of SOFA ( sequential organ failure assessment) score on echinocandin-exposure [ Time Frame: July 2020 ]
  9. Influence of APACHE II (Acute Physiology and Chronic Health Evaluation II) score on echinocandin-exposure [ Time Frame: July 2020 ]
  10. Influence of total protein on echinocandin-exposure [ Time Frame: July 2020 ]
  11. Influence of serum albumin on echinocandin-exposure [ Time Frame: July 2020 ]
  12. Influence of Ang-1 on echinocandin-exposure [ Time Frame: July 2020 ]
  13. Influence of Ang-2 on echinocandin-exposure [ Time Frame: July 2020 ]
  14. Influence of VEGF on echinocandin-exposure [ Time Frame: July 2020 ]
  15. Influence of inflammation (CRP) on echinocandin-exposure [ Time Frame: July 2020 ]
  16. Influence of fluid balance (mL) on echinocandin-exposure [ Time Frame: July 2020 ]
  17. Influence of prothrombin time on echinocandin-exposure [ Time Frame: July 2020 ]

Biospecimen Retention:   Samples Without DNA
Blood and BAL (bronchoalveolar lavage)


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill patients.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • < 18 years
  • DNR 2 or 3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045366


Contacts
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Contact: Isabel Spriet, PharmD, PhD +32 16 34 30 80 isabel.spriet@uzleuven.be
Contact: Ruth Van Daele, PharmD +32 16 34 30 80 ruth.vandaele@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Isabel Spriet, PharmD, PhD    +32 16 34 30 80    isabel.spriet@uzleuven.be   
Contact: Ruth Van Daele, PharmD    +32 16 34 30 80    ruth.vandaele@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
Investigators
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Principal Investigator: Isabel Spriet, PharmD, PhD UZ Leuven
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04045366    
Other Study ID Numbers: S54510
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Hypoalbuminemia
Critical Illness
Disease Attributes
Pathologic Processes
Hypoproteinemia
Blood Protein Disorders
Hematologic Diseases