External Validation of Model-Based Dosing Guidelines for Vancomycin, Gentamicin, and Tobramycin in Critically Ill Neonat
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ORIGINAL RESEARCH ARTICLE
External Validation of Model‑Based Dosing Guidelines for Vancomycin, Gentamicin, and Tobramycin in Critically Ill Neonates and Children: A Pragmatic Two‑Center Study Stan J. F. Hartman1 · Lynn B. Orriëns1 · Samanta M. Zwaag1 · Tim Poel1 · Marika de Hoop2,4 · Saskia N. de Wildt1,3,4
© The Author(s) 2020
Abstract Background The Dutch Pediatric Formulary (DPF) increasingly bases its guidelines on model-based dosing simulations from pharmacokinetic studies. This resulted in nationwide dose changes for vancomycin, gentamicin, and tobramycin in 2015. Objective We aimed to evaluate target attainment of these altered, model-based doses in critically ill neonates and children. Methods This was a retrospective cohort study in neonatal intensive care unit (NICU) and pediatric ICU (PICU) patients receiving vancomycin, gentamicin, or tobramycin between January 2015 and March 2017 in two university hospitals. The first therapeutic drug monitoring concentration for each patient was collected, as was clinical and dosing information. Vancomycin and tobramycin target trough concentrations were 10–15 and ≤ 1 mg/L, respectively. Target gentamicin trough and peak concentrations were 1 month but not for younger children.
2.2 Inclusion and Exclusion Criteria The electronic database of hospital admissions of both hospitals was screened for records of potential patients. All patients admitted to the NICU or PICU and who received at least one dose of vancomycin, gentamicin, or tobramycin were included in this initial screening. Inclusion criteria were as follows: postnatal age (PNA) 10% from the post-2015 dosing advice shown in Table 1), (2) received oral or enteral therapy, (3) started treatment before being admitted to the ICU, (4) required extracorporeal membrane oxygenation or hemofiltration therapy during antibiotic treatment, (5) were aged > 18 years PNA, or (6) had no accurate (steady-state) trough or peak concentration determined as part of TDM. This sixth exclusion criterion could mean patients in which no TDM sample was available at all, for example with transient clinical symptoms of infection or postsurgical antibiotic prophylaxis for which antibiotic therapy was discontinued before the first TDM sample was planned or if a vancomycin concentration was measured before steady state had been achieved. Steady state of vancomycin was defined as at least three half-lives between treatment start and blood sample, with the half-life
External Validation of Model-Based Dosing Guidelines in Critically Ill Neonates and Children Table 1 Overview of dose advice for vancomycin, gentamicin, and tobramycin in the Dutch Pediatric Formulary before and after the modelbased dose alterations in 2015 Drug and subgroup
Vancomycin Preterm,
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