Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time over MIC (calculated with the E-test) in overweight and non overweight critically ill patients
研究概览
简要总结
Overweight patients are susceptible to develop acute complications when they are admitted in an Intensive Care Unit (ICU). Severe infection can be associated with cardiovascular failure ('shock") and is associated with 35-50% mortality. One of the key issue to cure infection is to administer antibiotics. However, under dosing antibiotic is one of the main reason that explain treatment failure. There are very few data concerning particularities of antibiotic dosing in critically ill, overweight, patients. The aim of the present study is to describe the pharmacokinetic of two main antibiotics (doripenem and piperacillin/Tazobactam) in both overweight and non overweight critically ill patients presenting a septic shock. The investigators hypothesis is that usual dose for those antibiotic may be accurate in non overweight patients but is not in overweight patients.
详细描述
N=52 patients divided in 4*13 patients (13 per antibiotic and per group, overweight or non overweight).
Overweight is defined by a weight over 120kg. Antibiotic chosen by the intensivist in charge of the case. Doripenem 1g/8h with a 4h IV infusion whatever the patient's weight. Piperacillin/Tazobactam 4g IV (1h) and then 16g/24h IV continuously whatever the patient's weight.
Piperacillin/Tazobactam plasma dosage: after the first dose and then every 12h. Doripenem plasma dosage: after the first dose and then twice a day, at peak and residual value.
Usual plasma and urine samples for urea, creatinine, electrolytes, platelets and bilirubin each 24h.
Microbiology: bacterial identification and MIC measurement with E-test
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients in severe sepsis or septic shock defined by Bone criteria (proved or very suspected infection with organ impairment and/or need of vasopressive agent to keep a mean arterial pressure more than 65mmHg)
- •Patient requiring a treatment by study's antibiotics
- •Informed consent signed
- •Patient must be affiliated or beneficiary of a social medical insurance
- •Participation of patient to the trial must be noted in the medical file
- •Specific to overweight patients: Weight > 120kg
- •Specific to no overweight patients: Weight less than or equal to 120kg
排除标准
- •Pregnant women
- •Under age patient minor
- •Patient protected by law
- •Known allergy to study's antibiotics
研究组 & 干预措施
No overweight patient
Patient with weight less than or equal to 120kg
干预措施: Doripenem or Piperacillin/Tazobactam (Drug)
Overweight patients
Patient with weight more than 120kg
干预措施: Doripenem or Piperacillin/Tazobactam (Drug)
结局指标
主要结局
Time over MIC (calculated with the E-test) in overweight and non overweight critically ill patients
时间窗: up to Day 8
次要结局
未报告次要终点