# Pediatric septic acute kidney injury: personalizing antibiotic dosing through understanding acute kidney injury risk factors and biomarker profiles

> **NIH NIH K23** · CHILDREN'S HOSP OF PHILADELPHIA · 2020 · $180,330

## Abstract

PROJECT SUMMARY/ABSTRACT
Over 75,000 cases of pediatric severe sepsis occur in the US per year with mortality of 10-30%, and significant
risk of new disability in survivors. Acute kidney injury (AKI) complicates 25% of pediatric severe sepsis, and is
associated with further increased risk of mortality and disability. Dr. Fitzgerald’s goals are to define biomarker
phenotypes and antibiotic exposures associated with septic AKI, to use these to improve pharmacologic
models predicting vancomycin disposition, and test a strategy of personalized vancomycin prescribing and
dose adjustments in a pilot trial with a goal of increased antibiotic efficacy and lower toxicity to the kidney.
These results will inform future large interventional studies to reduce pediatric septic AKI, with the goal of
allowing children with sepsis to lead longer, healthier lives free from disability, aligning with NIDDK’s mission.
Candidate: Dr. Julie Fitzgerald, Assistant Professor of Pediatric Critical Care at The University of
Pennsylvania Perelman School of Medicine (PSOM) and the Children's Hospital of Philadelphia, is focusing
her research on patient-oriented clinical research in pediatric septic AKI. Dr. Fitzgerald’s immediate goals are
to prospectively study septic AKI risk factors; obtain research training in the application of pharmacometrics to
a specific pediatric critical illness and training in clinical trial implementation; and transition to research
independence. Her long-term goal is to improve health and quality of life for children with sepsis through
testing interventions to decrease sepsis-associated organ dysfunction. Dr. Fitzgerald’s career development
plan includes coursework in pharmacology and clinical trial management; individualized expert mentoring;
training by expert consultants in the proposed methodology; and completion of the proposed specific aims.
Environment: The outstanding research infrastructure, educational resources, and expert mentorship at the
candidate’s institution will support successful completion of the proposal. A research coordinator team will
assist with subject recruitment and study procedures, and departmental statisticians will assist with analyses.
Research: The study objectives are to define risk factors and biomarker phenotypes associated with septic
AKI, and to use these to improve performance of pharmacologic models of vancomycin disposition. The
objectives will be reached through the following specific aims: 1) to define biomarker phenotypes and
vancomycin exposures associated with septic AKI, 2) to optimize vancomycin population pharmacokinetic
model performance and identify targeted dosing strategies in silico, and 3) to determine the feasibility of a trial
implementing personalized vancomycin pharmacokinetic models at the bedside. In a prospective cohort of
critically ill children with severe sepsis, urine biomarkers, vancomycin concentrations, and medication exposure
data will be collected and association with AKI m...

## Key facts

- **NIH application ID:** 9891679
- **Project number:** 1K23DK119463-01A1
- **Recipient organization:** CHILDREN'S HOSP OF PHILADELPHIA
- **Principal Investigator:** Julie C. Hollows Fitzgerald
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $180,330
- **Award type:** 1
- **Project period:** 2020-01-15 → 2024-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9891679

## Citation

> US National Institutes of Health, RePORTER application 9891679, Pediatric septic acute kidney injury: personalizing antibiotic dosing through understanding acute kidney injury risk factors and biomarker profiles (1K23DK119463-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9891679. Licensed CC0.

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