A prospective, non-randomized Population Pharmacokinetic study of Colistin in critically ill patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters of Colistin
研究概览
简要总结
1.Screen critically ill patients admitted in ICU
2.Obtain consent if eligible.
3.Obtain the demographic details, baseline investigation results, primary diagnosis, medication history, etc
4.Estimate GFR using various formulas.
5.Obtain 24 hour urine sample for urinary creatinine clearance calculation.
6.Administer 5 mL of Iohexol IV bolus, obtain 4 blood samples of 2 mL each at 2,4,8 and 12 hour after administration to calculate GFR by iohexol plasma clearance method.
7.Collect 4 venous blood samples of 2 mL each after 2 h,8h,12h and between 18-24 hour after the administration of loading dose of colistin.
8.Collect 3 blood samples of 2 mL each after the steady state of colistin has been achieved at 1 h, 8 h and and 12 h of maintenance dose administration.
9.Analyse the date after getting the pharmacokinetic parameters of Colistin.
10.Prepare a population pharamacokinetic model including the significant covariates for Colistin dosing in critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Critically ill patients of age ≥18 years, getting CMS as part of their treatment based on suspected or confirmed infection caused by multidrug-resistant Gram-negative bacteria necessitating the administration of Colistin based on dosage regimens selected at the discretion of physicians.
- •Patient receiving intravenous Colistin with or without concomitant administration of Colistin through other routes (inhalational/intrathecal).
- •Critically ill patients will be characterized by a state of poor health accompanied by dysfunction of vital organs, presenting a significant risk of impending death without immediate medical intervention, and with the possibility of recovery, as determined by the attending physician.
排除标准
- •No consent
- •Pregnancy or breastfeeding
- •Hypersensitivity to Colistin or Iohexol
- •Colistin administration within 1 week prior to enrolment.
- •Patients on drugs interacting with Iohexol.
结局指标
主要结局
Pharmacokinetic parameters of Colistin
时间窗: 1.After loading dose of Colistin-1st day | 2.After steady state of Colistin is achieved-after 9 infusions
次要结局
- Identification of covariates of significance for the establishment of population pharmacokinetic model.
研究者
Dr Samir Malhotra
Post Graduate Institute of Medical Education & Research, Chandigarh