Target Attainment of TDM-guided Continuous Infusion of Piperacillin/Tazobactam and Cefepim in Critically Ill Patients: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- to determine the percentage of patients who met the PK/PD targets at 24 hours
研究概览
简要总结
Although alternative dosing strategies can improve antimicrobial exposure in critically ill patients, the high PK variability in this population means that some may still receive sub-optimal antibiotic exposure leading to unfavourable clinical outcomes.
Therapeutic drug management (TDM) guided dosing is the only safe and effective way to ensure that all critically ill patients achieve therapeutic antimicrobial exposures and to minimise the likelihood of toxicity.
For experts, TDM should be a standard of care, in particular for β-lactams. Nevertheless, because of the assay method for β-lactams and the need for bioanalytical experts, delays in obtaining results frequently occurred. These barriers, combined with difficulties in the interpretation of TDM results, need to be addressed in order to increase its routine utilization. Consequently, study aiming at identify which subgroup of patients or infection are more likely to benefit from TDM are urgently warranted This prospective observational study aimed at evaluating target attainment of piperacillin/tazobactam (PIP/TAZ) and cefepim (CEF) with the use of a Therapeutic Drug Monitoring (TDM) in critically patients during the routine care
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Minimun age limits 18 years
- •Critically ill patient receiving piperacillin or cefepim administered continuously
排除标准
- •Beta lactam allergy
- •Pregnancy
- •Age less than 18 years
结局指标
主要结局
to determine the percentage of patients who met the PK/PD targets at 24 hours
时间窗: Day 1
PK/PD target was defined as follows: Concentration of piperacillin or cefepim between a lower and a upper limit: * The lower limit was defined as estimated free concentration above 4 times the epidemiological cut-off value of suspected bacteria * The upper limit was based on known limit of neurotoxicity, namely 35 and 160 mg/L for cefepim and piperacillin, respectively Consequently : * for piperacillin : the PK/PD target is considered to be reach if the free concentration of PIPERACILLIN/TAZOBACTAM is between 32 and 160 mg/l * for cefepim : the PK/PD target is considered to be reach if the free concentration of CEFEPIM is between 4 and 35 mg/l
次要结局
- to determine the percentage of patients who met the PK/PD targets "exposure" at 24 hours(Day 1)
- factors associated with target attainment at day 1(Statistical analysis after 2 years of inclusion)
- factors associated with dose changing(Statistical analysis after 2 years of inclusion)