A Study to Evaluate the Predictive Performance of a Target-controlled Infusion Model for the Administration of Cefepime to Intensive Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 主要终点
- Median Absolute Preditive Error (MdAPE, %) of predicted versus measured cefepime plasma concentrations (mg/L)
研究概览
简要总结
For this study, a previously developed population pharmacokinetic (popPK) model for cefepime (Jonckheere et al., submitted to JAC) was programmed in Rugloop vII, which is a software program to drive an infusion pump. By entering patient data (such as gender, serum creatinine, age and weight) in Rugloop II, a patient-specific dose will be calculated and given to the patient. This concept is known as Target Controlled Infusion (TCI). The aim of this study is to prospectively validate the popPK model using TCI.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients of 18 years of age or older, admitted to the hospital ICU and requiring administration of cefepime as part of their treatment
- •Patients within the weight range of 50 -120kg
- •Patients with calculated creatinine clearance within the range 15 to > 90 ml/min, allocated to one of three groups as described above.
- •Written informed consent, or if not possible surrogate consent, or if not possible declaration for inclusion in an emergency, patient informed consent being signed as soon as possible.
- •Patient with an arterial catheter in place for other reason than the current study purpose
排除标准
- •Patients displaying acute or chronic renal failure requiring renal replacement therapy
- •Pregnancy
- •Moribund patients
- •Known sensitivity or allergy to cefepime
- •Inclusion in another study involving antimicrobial treatment.
- •Patient participating in a research for which a period of exclusion is currently required by other study protocol, ethical committee or health authority.
- •Patient already previously included in the trial
研究组 & 干预措施
TCI group
Patients who receive cefepime based on TCI for a maximum of 5 days with a target concentration of cefepime of 16 mg/L.
干预措施: TCI group (Other)
结局指标
主要结局
Median Absolute Preditive Error (MdAPE, %) of predicted versus measured cefepime plasma concentrations (mg/L)
时间窗: During the first 5 days of cefepime therapy
次要结局
- Percentage of patients with Neurotoxicity related to cefepime based on Naranjo criteria(Evaluation during the first 5 days of cefepime therapy)
- Negativation of microbiological cultures(Evaluation during the first 5 days of cefepime therapy)
- Percentage of patients with clinical cure(At the end of the study (maximum 5 days after inclusion))
研究者
Stijn Jonckheere
Principal Investigator
Onze Lieve Vrouw Hospital