Pharmacokinetics of Colistin in Critically-ill Patients With Acute Kidney Injury Who Receive Sustained Low-Efficiency Dialysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve [AUC]
研究概览
简要总结
Colistin was developed in the 1960s and preliminary pharmacokinetic studies were performed at that time. Dosing recommendations, on the basis of these pharmacokinetic studies, are listed in the drug's product information. However, there are no optimal dosing recommendations for patients with acute kidney injury who receive sustained low-efficiency dialysis. Furthermore, the science of antibiotic dosing ("pharmacodynamics") has changed significantly since the 1960s and it is quite possible that the dosing recommendations listed in the product information are not optimal. Furthermore, even though physicians refer to "colistin" administration, the only intravenous form of the drug is colistin methanesulfonate (CMS). CMS is converted in the body to colistin. Both CMS and colistin have different pharmacokinetic and antimicrobial activities. For this reason, we, the investigators at the Mahidol university, are performing a pharmacokinetic study of the intravenous CMS/colistin in patients requiring sustained low-efficiency dialysis. Plasma concentrations will be determined around a CMS/colistin dose once the drug has reached steady state. Microbiologic and clinical endpoints will be determined and will be correlated with these concentrations. The measurement of CMS and colistin levels will be determined by a laboratory in Australia.
详细描述
At baseline (upon signing informed consent), the following information will be collected: Demographic data - age, sex, height, weight, state of birth, underlying illnesses, underlying infection, immunosuppression, antibiotic use, laboratory results, current medication use, any other prior medical problems/history and clinical outcomes.
The research coordinator will contact the patient on days 14, 28 and 90 days after the infection to determine clinical outcome. If the patient is still an inpatient the research coordinator will visit the patient in their hospital room to evaluate the patient's health status. This visit will take about 10 minutes. If the patient has been discharged from the hospital, the patient will be contacted by telephone by the research coordinator to determine the health status, if no recent electronic medical record exists. This telephone contact will take about 10 minutes.
Blood work and microbiologic samples to be collected:
Collection of ten samples of 4 mL blood each day during two days of colistin treatment (the dialysis day and non-dialysis day) of colistin therapy will occur. These samples will be collected:
immediately pre-dose, at the end of the colistin infusion, 60 minutes after the end of the colistin infusion, 2 hours after the end of the colistin infusion, 5 hours after the end of the colistin infusion, 8 hours after the end of the colistin infusion, 12 hours after the end of the colistin infusion (or immediately prior to the next dose if the drug is being given every 12 hours).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females greater than 18 years of age.
- •All patients will remain in the hospital for pharmacokinetic sampling.
- •All subjects must be on the medication colistin as part of their standard of care.
- •All subjects must be on sustained low-efficiency dialysis
排除标准
- •Pregnancy and lactation
- •The patients receiving colistin inhalation
研究组 & 干预措施
blood draws
All patients enrolled will have PK blood samples obtained around a colistin dosing
干预措施: Colistin Sulfomethate (Drug)
结局指标
主要结局
Area under the concentration-time curve [AUC]
时间窗: 24 hours
The area under the plasma drug concentration-time curve (AUC) reflects the actual body exposure to colistin after administration of a dose of colistin and is expressed in mg\*h/L. Predose, and 1, 2, 5, 8, 12 hours after administration
Maximum Plasma Concentration [Cmax]
时间窗: 24 hours
Cmax is the maximum (or peak) serum concentration that colistin achieves in a specified compartment or test area of the body after colistin has been administered and before the administration of a second dose. Predose, and 1, 2, 5, 8, 12 hours after administration.
次要结局
- Treatment-Related Adverse Events CTCAE v4.0(14 days)