The Analysis of Factors Influencing the Apparent Volume of Distribution of Imipenem in Septic Shock Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- the apparent volume of distribution
研究概览
简要总结
The study measures the plasma concentrations of imipenem in septic shock patients and non-septic shock patients and observes hypoalbuminemia and the impact of the severity of critical illness on Vd
详细描述
Severe sepsis and septic shock are major causes of mortality in intensive care unit(ICU) patients.Correct and adequate antibiotic coverage is essential but can be complex as a result of fluid resuscitation, hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on pharmacokinetics(PK).Such changes will significantly distort the normal anti-biotic PK profile, resulting in drug exposure that is markedly different from the 'healthy volunteer.'The apparent volume of distribution is one of important PK parameters.Vd determines the loading dose. This review article considers these issues in detail, summarizing the key changes in antibiotic Vd in the critically ill, and providing general suggestions how to optimization of antibiotic dosing to manage Vd challenges.50 patients who receives the theapy of imipenem are included in this study.Whether hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on Vd will be evaluted.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 years old and 80 years old;
- •Admitted to the ICU;
- •Patients diagnosed as septic shock requiring the therapy of imipenem(0.5g q6h or 1.0g q8h;
排除标准
- •Patient participated in another interventional trial before enrollment
- •Allergy, hypersensitivity or a serious reaction to imipenem;
- •patients with ECMO and(or)CRRT.
研究组 & 干预措施
septic shock
Patients with septic shock treat with Imipenem
干预措施: Imipenem (Drug)
non-septic shock
Patients with infection but not septic shock treat with Imipenem
干预措施: Imipenem (Drug)
结局指标
主要结局
the apparent volume of distribution
时间窗: Day1, Day 3, Day 7
The imipenem plasma concentrations are measured at different time to calculate Vd
次要结局
未报告次要终点
研究者
Songqiao Liu
MD. PHD
Southeast University, China
