Optimal Dosing of Vancomycin in an Adult Population of Hemato-oncology: a Nomogram Based on a Bayesian Population Model to Predict Initial Dosage of Vancomycin
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pharmacokinetic Parameters : Volume of Distribution
研究概览
简要总结
This is a single-center prospective pharmacokinetic study. The principal objective is to collect new data among patients with hematologic cancer to develop a Bayesian population pharmacokinetic model and to improve dose adjustment of intravenous vancomycin. Approximately 40 subjects meeting the inclusion and no exclusion criteria will be enrolled in the study. Vancomycin blood concentration will be measured at steady-state at three different moment for each participant : immediately before the infusion, 1 hour after the infusion and during the elimination phase (at 3, 4 or 5 hours after the infusion). This additional vancomycin serum concentration in the elimination phase will be used to estimate more precisely the vancomycin pharmacokinetic parameters in this specific population including the distribution volume and the elimination of the molecule. Ultimately, the purpose of this study is to create a nomogram to predict the optimal initial vancomycin dosing in adult patients with a hematologic cancer.
详细描述
STUDY DESIGN:
Prospective, monocentric, pharmacokinetic study.
Adults who have been diagnosed with a hematologic malignancy, are hospitalized at Maisonneuve-Rosemont hospital and received at least 3 doses of intravenous vancomycin.
Pharmacokinetic parameters: Serum vancomycin concentration measured at steady state just before the beginning of the infusion (trough), 1 hour after completion of the infusion (peak) and between 3 to 5 hours after the end of the infusion (additional blood draw during the elimination phase).
RECRUITMENT PROCESS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 and over;
- •Subjects diagnosed with a hematologic cancer;
- •Subjects hospitalized at Maisonneuve-Rosemont hospital between February 2021 and August 2021;
- •Intravenous vancomycin treatment prescribed by a doctor;
- •Subjects received at least 3 doses of intravenous vancomycin.
排除标准
- •Non-malignant diagnosis (aplastic anemia and rare metabolic diseases);
- •Subjects admitted to a critical care unit;
- •End-stage renal disease (GFR < 15 mL/min/1.73m2);
- •Patients undergoing dialysis/renal replacement therapy;
- •Acute kidney injury at the moment of the first vancomycin dosage (definition adapted from KDIGO criteria):
- •Increase in serum creatinine by ≥ 26.5 umol/L within 48 hours or
- •Increase in serum creatinine to ≥ 1.5 times baseline within prior 7 days
- •Pregnant women;
- •Severely burn patients;
- •Inability to give free and informed consent.
结局指标
主要结局
Pharmacokinetic Parameters : Volume of Distribution
时间窗: During intravenous vancomycin treatment assessed to 72 hours
Estimated from vancomycin serum concentrations and patient characteristics
Pharmacokinetic Parameters : Vancomycin clearance
时间窗: During intravenous vancomycin treatment assessed to 72 hours
Estimated from vancomycin serum concentrations and patient characteristics
次要结局
- Serum Vancomycin Peak Concentration(60 minutes after the end of the infusion)
- Area Under the concentration-time Curve (AUC)(between 0 to 24 hours during vancomycin administration)
- Serum Vancomycin Through Concentration(5 minutes before the selected infusion)
- Serum Vancomycin Elimination Phase Concentration(3 to 5 hours after the end of the infusion (+/- 30 minutes))