Pharmacokinetics and Pharmacodynamics of High-Dose Piperacillin/Tazobactam in Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Serum Maximum Concentrations for Piperacillin
研究概览
简要总结
Worldwide rates of obesity have doubled in the last 30 years, and obesity has been associated as a risk factor for hospital-acquired infections and increased occurrence of death in critically-ill patients. Piperacillin/tazobactam is a commonly prescribed antibiotic for critically ill patients with an infection, however, limited information exists for dosing this drug in obese patients. In these limited reports, standard doses of piperacillin/tazobactam given to the small number of obese patients resulted in lower blood concentrations, which could lead to inadequate killing of bacteria. The purpose of this study is to compare blood concentrations from standard piperacillin/tazobactam dosing compared to higher dosing regimens in obese patients. This study will also include information on the safety and tolerability of the higher dose regimens. The study investigators believe that the higher dosing regimen will produce adequate blood levels in obese patients and will not add any more risk of harm to obese patients receiving this higher dose.
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 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI greater than or equal to 30 kg/m2
- •Weight at least 105 kg
- •Age 18-89 years of age
- •Prescribed piperacillin/tazobactam at standard doses for suspected or confirmed infection(s)
- •English or Spanish speaking
- •Central line access
排除标准
- •Do not meet specified inclusion criteria
- •Hepatic impairment classified by Child-Pugh Class B or greater
- •Documented pre-existing seizure disorder
- •Documented pre-existing hematologic disorder
- •Pregnancy
- •Documented allergy or contraindication to beta-lactams or tazobactam
研究组 & 干预措施
Standard Dose to High Dose Piperacillin/Tazobactam
Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
干预措施: Piperacillin/Tazobactam Standard Dose to High Dose (Drug)
结局指标
主要结局
Serum Maximum Concentrations for Piperacillin
时间窗: 0, 1, 3, and 6 hours post-dose
Pharmacokinetic parameters for piperacillin of maximum serum concentration (Cmax) will be measured in both standard dosing and high dosing.
Serum Minimum Concentrations of Piperacillin
时间窗: 0, 1, 3, and 6 hours post-dose
Minimum serum concentrations (Cmin) of piperacillin will be measured in both standard and high doses
次要结局
- Half-life of Piperacillin(0, 1, 3, and 6 hours post-dose)
- Volume of Distribution of Piperacillin(0, 1, 3, and 6 hours post-dose)
研究者
Steven Forland
Clinical Pharmacy Specialist - Infectious Diseases
Loma Linda University
