Pharmacokinetics of Imipenem in Critically Ill Patients With Life-threatening Severe Infections During Support With Extracorporeal Membrane Oxygenation
试验速览
- 阶段
- 4 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Concentration of imipenem in plasma
研究概览
简要总结
Extracorporeal membrane oxygenation (ECMO) has become increasingly used for lifesaving respiratory and/or cardiac failure support in critically ill patients, including those with life-threatening severe infections. This cardiopulmonary bypass device has been shown to enhance the profound pathophysiological changes in this patient population, resulting in an alteration of the pharmacokinetics (PK) of antimicrobial agents. The aim of this study was to determine the effect of ECMO on the PK of imipenem in critically ill patients supported by this cardiopulmonary bypass device.
Methods The study was conducted in critically ill patients with respiratory and/or cardiac failure and suspected severe nosocomial infections who were supported by ECMO. All patients received a 1-h infusion of 0.5 g of imipenem every 6 h and imipenem PK studies were carried out on the fourth dose of drug administration.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age >18 year
- •Patients who diagnosed as severe sepsis
- •Admitted into the ICU
- •Supported with ECMO
排除标准
- •Patients who pregnant
- •Patients who have documented hypersensitivity to carbapenem
研究组 & 干预措施
Imipenem ECMO
1-h infusion of 0.5 g of imipenem, q6h
干预措施: Imipenem (Drug)
结局指标
主要结局
Concentration of imipenem in plasma
时间窗: 6 hour after the imipenem dose
Individual concentration of imipenem in plasma
次要结局
未报告次要终点
研究者
Sutep Jaruratanasirikul
Principle Investigator
Prince of Songkla University