A Pharmacokinetic Study to Evaluate the Use of a Novel Clinical Decision Support Tool, Lyv, in Achieving AUC24/MIC > 400 in Pediatric Patients on Vancomycin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- AUC24/MIC target attainment of vancomycin after first dose using the clinical decision support tool compared to dosing using the current hospital method
研究概览
简要总结
This study will evaluate the pharmacokinetic and pharmacodynamic dosing properties of intravenous vancomycin in pediatric patients using a novel computer decision support (CDS) tool called Lyv. Dosing will be individualized based on AUC24/MIC. The results will be compared to matched historical controls.
详细描述
This study is a prospective pharmacokinetic study of pediatric patients receiving IV vancomycin at the University of Maryland. Patients may be in the Pediatric Intensive Care Unit (PICU), Neonatal Intensive Care Unit (NICU), the Intermediate Care Unit (IMC) or the general pediatric ward.
The study design will be comparing historical controls, who are retrospective patients that had IV vancomycin dosed based on pharmacists' calculations, to prospective patients who will have vancomycin dosing based on a clinical decision support tool.
Patients requiring IV vancomycin therapy will be selected on the basis of inclusion and exclusion criteria. The study procedures will be explained to all patients and written informed consent will be obtained from each subject prior to enrollment.
Historical controls will be selected based on the same inclusion and exclusion criteria to minimize bias. Full HIPPA waiver will be used for these patients.
All patients who consent to enrolling in the study will have vancomycin dosing based on the Clinical Decision Support (CDS) tool. Results will be compared to historical controls. Patients must be enrolled within the first 24 hours of initiation of vancomycin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized infants and children from postmenstrual age of 38 weeks to age 19 years Requiring IV vancomycin, regardless of indication
- •Parent or legally authorized representative is willing to provide permission and sign the informed consent document; subjects assent, when appropriate
- •Hospitalized neonates, infants, children, adolescents who require, but have not been initiated on intravenous vancomycin therapy
排除标准
- •Patients who had received vancomycin during previous 2 weeks
- •Patients with end-stage renal disease, receiving hemodialysis or receiving continuous renal replacement therapy
- •On oral or intraperitoneal vancomycin
- •Receiving extracorporeal therapy, including extracorporeal membrane oxygenation, continuous renal replacement therapy, and extracorporeal liver support
- •Will only receive a single dose of vancomycin
- •Known to be pregnant
- •Is brain dead or has suspected brain death
结局指标
主要结局
AUC24/MIC target attainment of vancomycin after first dose using the clinical decision support tool compared to dosing using the current hospital method
时间窗: 2-6 hours post first dose
Vancomycin level will be drawn after first dose of antibiotic. The level will be entered into the CDS tool and AUC24/MIC target attainment will be generated. If the level is not in range, the CDS tool will generate a new dose for future doses.
次要结局
- To characterize vancomycin pharmacokinetics and evaluate the factors that affect variability in achievement of an AUC24/MIC > 400 in pediatric patients(From start to end of antibiotic therapy, or a max of 7 days)
- To evaluate the incidence of nephrotoxicity for dosing vancomycin using the decision support tool compared to dosing using the current hospital method(From start to end of antibiotic therapy, or a max of 7 days)
- To evaluate the accuracy of the clinical decision support system in predicting the AUC24/MIC(From start to end of antibiotic therapy, or a max of 7 days)
研究者
Siddhartha Dante
Assistant Professor
University of Maryland, Baltimore