Detailed Assessment of Augmented Renal Clearance in a Large Mixed Intensive Care Unit Population

Last updated: May 15, 2019
Sponsor: Universitaire Ziekenhuizen Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03954275
S61364
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Having at least one 24h creatinine clearance measurement available

Exclusion

Exclusion Criteria:

  • Any form of renal replacement therapy

Study Design

Total Participants: 10000
Study Start date:
October 01, 2018
Estimated Completion Date:
September 30, 2019

Study 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.

Connect with a study center

  • UZLeuven

    Leuven, 3000
    Belgium

    Active - Recruiting

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