Vancomycin and Acute Kidney Injury in Sepsis Treatment - Pharmacologic Modeling Intervention
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility - personalized dose adjustment performed
研究概览
简要总结
The goal of this clinical trial is to determine if vancomycin dosing in children with sepsis can be improved by using updated, personalized dosing models that account for new markers of an individual's kidney function. Vancomycin is prescribed based on the known information of how the body breaks this medicine down. Vancomycin may not be effective if blood levels of the medicine are too low. Vancomycin has potential side effects, including the possibility of injury to the kidney. These side effects usually happen when blood levels of vancomycin are too high. There are guidelines for the range of vancomycin blood levels doctors should target to treat an infection and lower the risk of side effects. Children with sepsis may metabolize vancomycin at different rates, faster or slower, than children who do not have sepsis. For these reasons, the current dosing strategy may lead to a higher risk of kidney injury or a risk of not adequately treating an infection in children with sepsis. The investigators' goal is to use new vancomycin dosing equations to improve the ability to select the right dose of vancomycin. The main questions this trial aims to answer are:
- Is it feasible to use personalized models of vancomycin dosing in children with sepsis?
- Will personalized models of vancomycin dosing achieve vancomycin blood levels in acceptable ranges?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >1 month and <18 years
- •Weight >5kg and <50kg
- •Vancomycin intended duration of therapy ≥48 hours
- •Admitted to intensive care unit with suspected or confirmed sepsis
- •Either sepsis-induced respiratory (invasive mechanical ventilation) or cardiovascular (vasoactive infusion) dysfunction as part of sepsis-associated organ dysfunction (these organ dysfunctions may be improving or resolved at the time of enrollment)
排除标准
- •Serum creatinine elevated and meets criteria for trough-based dosing by local Clinical Pharmacy
- •Methicillin resistant Staph aureus minimum inhibitory concentration (MIC)>1
- •Central nervous system infection
- •Extracorporeal support (extracorporeal membrane oxygenation, continuous renal replacement therapy)
- •Patients on chronic dialysis therapy
- •Patients with known history of delayed vancomycin clearance based on local pharmacy records
研究组 & 干预措施
Personalized vancomycin Pharmacokinetic model for dose adjustments
Enrolled patients who are prescribed vancomycin by the clinical team will transition to the study-determined empiric vancomycin dosing at the time of enrollment, 12mg/kg/dose administered as an extended intravenous (IV) infusion over 2 hours given every 6 hours. Urinary neutrophil gelatinase-associated lipocalin (NGAL) will be measured as soon as possible after enrollment. Dosage adjustments will be made using the personalized vancomycin pharmacokinetic (PK) model incorporating the NGAL level once resulted. Daily urinary NGAL will be measured while on vancomycin therapy and in the intensive care unit (ICU) to evaluate for ongoing changes in renal function that may necessitate further dosage adjustments using the personalized vancomycin PK model, until clinically stabilized. Patients will undergo vancomycin area under the curve (AUC) monitoring with three timed blood draws for vancomycin concentrations with each vancomycin dosing change with a goal AUC target range of 400-600.
干预措施: personalized dosing adjustment of vancomycin (Other)
结局指标
主要结局
Feasibility - personalized dose adjustment performed
时间窗: From enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment
Percentage of enrolled patients in which urinary neutrophil gelatinase-associated lipocalin is measured and used to make a vancomycin dosing recommendation
次要结局
- Feasibility - Use of study-determined empiric vancomycin dosing(From enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment)
- Feasibility - Area under the curve sampling attainment on study empiric vancomycin dosing(From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment)
- Feasibility - Dosing change based on urinary neutrophil gelatinase-associated lipocalin level(From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment)
- Feasibility - Area under the curve sampling attainment after personalized dose adjustment(From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment)
- Efficacy and safety - area under the curve in goal range(From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment)
- Efficacy and safety - resolution of gram positive infection(From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment)
- Efficacy and safety - development of acute kidney injury(From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment)
- Efficacy and safety - treatment failure(From study enrollment to the longer of 7 days after the completion of vancomycin therapy or through 30 days from enrollment)