Monitoring of Piperacillin-Tazobactam and Meropenem Plasmatic Levels in Critical Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy .
研究概览
简要总结
The aim of this study is to establish the Piperacillin-Tazobactam and Meropenem Plasmatic Levels to know if it´s necessary to make some adjustment in the recommended dose regimen.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above 18 years old.
- •Hospitalized in the Intense Care Unit.
- •Patients treated with Piperacillin-Tazobactam or Meropenem.
- •Septic shock.
- •Renal hyper clearance.
- •Gram-negative bacillary bacteremia.
- •Continuous renal replacement technique.
- •Obesity (BMI> 40).
排除标准
- •Patients under 18 years old.
- •Pregnant women.
研究组 & 干预措施
Piperacillin-Tazobactam or Meropenem Cohort
Patients hospitalized for sepsis or septic shock that are treated with Piperacillin-Tazobactam or Meropenem and meet all the inclusion criteria and none of the exclusion criteria.
干预措施: Piperacillin/tazobactam or Meropenem (Drug)
结局指标
主要结局
Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy .
时间窗: Up to 12 months after the antibiotic administration
The chosen efficiency parameter is that 100 % of the time the concentration remains 4 times above the minimum inhibitory concentration (MIC), the exact minimum inhibitory concentration (MIC) of the used antibiotic will be determined by E-test by the Microbiology Service which means that the seric concentrations asociated with the maximum therapeutic efficacy are: * For Meropenem 2mg/dl, which means reaching a concentration in T0 \>8 mg/dL. * For Piperacillin-Tazobactam 16 mg/dL, which means reaching a concentration in T0 \>64 mg/dL.
次要结局
- Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with renal hyper clearance.(Up to 12 months after the antibiotic administration)
- Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with Gram-negative bacillary bacteremia.(Up to 12 months after the antibiotic administration)
- Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with continuous renal replacement technique.(Up to 12 months after the antibiotic administration)
- Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with ExtraCorporeal Membrane Oxygenation.(Up to 12 months after the antibiotic administration)
- Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with morbid obesity.(Up to 12 months after the antibiotic administration)
- Determine in the total cohort if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy.(Up to 12 months after the antibiotic administration)
- Determine the association between the supra-therapeutic levels and the appearance of toxicity.(Up to 12 months after the antibiotic administration)