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A prospective feasibility study evaluating the implementation of model-informed precision dosing in critically ill
Izgi Bayraktar1, Merve Kaşıkcı2, Zuhal Benek1
1Department of Clinical Pharmacy, Faculty of Pharmacy, Hacettepe University, Ankara, Türkiye.
Insights
Model-Informed Precision Dosing (MIPD) shows promise for optimizing antibiotic therapy in critically ill children, though further trials are needed to confirm its clinical benefits and refine its implementation in pediatric intensive care.
Area of Science:
- Pediatric critical care medicine
- Pharmacokinetics and pharmacodynamics
- Clinical pharmacology
Background:
- Optimal antibiotic exposure is challenging in critically ill children due to physiological variability.
- Conventional dosing often fails to achieve therapeutic targets for narrow therapeutic index antibiotics like vancomycin and amikacin.
Purpose of the Study:
- To evaluate the feasibility and methodological performance of Model-Informed Precision Dosing (MIPD) in a pediatric intensive care unit.
- To compare MIPD-guided dosing with standard-of-care (SoC) for vancomycin and amikacin in critically ill children.
Main Methods:
- Prospective, pragmatic feasibility study with a comparator arm.
- Observational analysis of pediatric patients receiving vancomycin or amikacin, managed with either MIPD or SoC.
- Primary outcomes: prediction accuracy and model fit; Secondary outcomes: dose optimization, inflammatory markers, renal safety, treatment duration, and mortality.
Main Results:
- Model fit showed modest improvement for vancomycin with MIPD, while remaining unchanged in the SoC group.
- Clinical outcomes were similar between groups; however, the MIPD group showed numerically greater, though nonsignificant, reductions in CRP and procalcitonin.
- Baseline imbalances in inflammatory markers confounded interpretation of clinical outcomes.
Conclusions:
- MIPD is a potentially valuable approach for optimizing antibiotic exposure in pediatric intensive care.
- Further multicenter trials are necessary to confirm clinical benefits and optimize MIPD implementation in this population.
Abstract:
Achieving optimal antibiotic exposure in critically ill pediatric patients is difficult due to (their) dynamic physiology and variability. Conventional weight-based regimens often fail to reach pharmacokinetic/pharmacodynamic (PK/PD) targets for narrow therapeutic index agents such as vancomycin and amikacin. Model-Informed Precision Dosing (MIPD), which integrates Bayesian forecasting with population pharmacokinetics (popPK), offers a potentially valuable yet underexplored approach in pediatric intensive care to better attain and sustain target exposure. This study was designed as a prospective, pragmatic feasibility study with a comparator arm, employing observational analyses to evaluate the implementation and methodological performance of MIPD in a tertiary pediatric intensive care unit. Pediatric patients receiving vancomycin or amikacin were managed either with MIPD-guided dosing using a clinical decision support platform or with standard-of-care (SoC) dosing. Primary outcomes included prediction accuracy (a priori vs. a posteriori) and model fit, defined by the agreement between observed and model-predicted concentrations and categorized as poor, intermediate, or good. Secondary outcomes assessed dose optimization, inflammatory response, renal safety, treatment duration, and mortality. Forty-one patients (median age 38.6 months) were enrolled; Patients were initially allocated to either MIPD or SoC; however, the final analytic groups were defined as-treated, with 12 receiving active MIPD-guided dose adjustments and 29 managed under SoC dosing. Some baseline differences were observed between groups, particularly in inflammatory markers. Clinical outcomes were similar between groups, with numerically greater but nonsignificant reductions in CRP and procalcitonin in the MIPD group. However, these findings were confounded by baseline imbalances and should be interpreted cautiously. Model fit remained unchanged in the SoC group but showed modest improvement for vancomycin under MIPD. Larger, multicenter trials are warranted to confirm clinical benefit and optimize implementation in pediatric intensive care.
Clinical Trial Registration:
ClinicalTrials.gov, identifier NCT07315438.
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