Clinical Outcome Study of High-dose Meropenem in Sepsis and Septic Shock Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- SOFA score change
研究概览
简要总结
Sepsis and septic shock patients are considered to have a high risk of complications and death. Appropriate antimicrobial therapy plays an important role in determining outcomes in septic patients. However, pathophysiologic changes associated with critical illness have an impact on pharmacokinetics of antimicrobials. In addition, increasing bacterial resistance is also a growing concern, especially in intensive care units., Consequently, standard antimicrobial dose may not be sufficient to achieve pharmacokinetic/pharmacodynamic target in sepsis and septic shock patients. The purpose of this study is to compare a therapy between meropenem standard dose and meropenem high dose in the treatment of sepsis and septic shock
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adults (18 years and older) with sepsis and/or septic shock according to SEPSIS-3 criteria and receive meropenem within 1 hour after diagnosis
- •Informed consent signed by patient or their legally authorized representative
排除标准
- •Subjects with infective endocarditis
- •Subjects with central nervous system infection
- •Subjects who requires surgical condition within 72 hours after randomization
- •Subjects on extracorporeal membrane oxygenation (ECMO) within 3 days after randomization
- •Subjects with active seizure
- •History of receiving meropenem within 1 week prior to randomization
- •Pregnancy women and lactation
- •Known allergy to meropenem
- •Not complete a 72-hour course of empirical meropenem treatment
研究组 & 干预措施
Meropenem standard dose
Meropenem 1 g every 8 hours
干预措施: Meropenem standard dose (Drug)
Meropenem high dose
Meropenem 2 g every 8 hours
干预措施: Meropenem high dose (Drug)
结局指标
主要结局
SOFA score change
时间窗: Change from Baseline SOFA score at day 4
The Sequential organ failure assessment (SOFA) score describe the time course of multiple organ dysfunction. The SOFA score is composed of scores for six organ systems (respiratory, cardiovascular, neurological, hepatic, renal and coagulation). The function of six organ systems is scored from 0 (no organ dysfunction) to 4 (severe organ dysfunction), and the individual organ scores are then summed to a total score between 0 and 24. Primary outcome is assessing change between SOFA score at baseline and SOFA score at day 4 after treatment by meropenem
次要结局
- Mortality(14 and 28 days)
- Length of hospital stay(14 and 28 days)
- Duration of mechanical ventilator(14 and 28 days)
- Length of ICU stay(14 and 28 days)
- %T > MIC(Day 1)
- Clinical cure(Day 3, 5, 7, 10 and 14)
- Microbiological cure(Day 3, 5, 7, 10 and 14)
- Duration of vasopressor agents(14 and 28 days)
研究者
Tospon Lertwattanachai
Principal Investigator
Mahidol University