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Clinical Trial Summary

This multi-center retrospective cohort study presents a detailed assessment of augmented renal clearance (ARC) in a mixed population of adult critically ill patients. Epidemiology of ARC will be studied in detail in a very heterogeneous population. Risk factors for ARC will be identified and a predictive scoring system for ARC ready to use in clinical practice will be constructed and validated. Performance of estimators of kidney function will be measured and a cutoff for ARC will be determined for the best estimator. Finally clinical impact of ARC will be explored using vancomycine and aminoglycosides levels as surrogate marker.


Clinical Trial Description

Augmented renal clearance will be assessed in detail in a very large and heterogeneous adult critically ill population. Analysis will be conducted retrospectively on a multi-center database collected by the M@tric research group. M@tric collects data from all intensive care units (surgical, medical, cardiac) in 3 Belgian University Hospitals (Leuven, Ghent, Antwerp).

Anonymised admission, demographic, clinical and laboratory data collected from 2013 until the present will be retrieved from the M@tric database. These data will then be coded and analysed in R statistical software. ARC will be defined based on a 24h creatinine clearance (CrCl24h) >=130ml/min/1.73m².

Epidemiology and risk factors for ARC will be studied in order to confirm and clarify past studies which have mostly been done in rather small and specific subsets of patients. A predictive algorithm for ARC will be trained and subsequently validated for use in clinical practice. Moreover this algorithm will be compared to existing scoring systems, which have not yet found their way into clinical practice. This algorithm will provide the ability to anticipate ARC on the intensive care unit. Also use of formulae estimating renal function will be evaluated in this population. These estimators will be compared to the CrCl24h, which is considered the golden standard in clinical practice. A cutoff for the best estimating formula in order to detect ARC will be calculated. Finally the impact of ARC on serum levels of hydrophilic molecules likes vancomycine and aminoglycosides will be studied. As this research follows a retrospective design these levels will be used a surrogate marker for clinical impact. This will potentially point out some opportunities for future research on the clinical impact of ARC. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03954275
Study type Observational
Source Universitaire Ziekenhuizen Leuven
Contact Matthias Gijsen, PharmD
Phone 16 340087
Email matthias.gijsen@uzleuven.be
Status Recruiting
Phase
Start date October 1, 2018
Completion date September 2019

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