Pharmacokinetics of Tobramycin Administered at the Beginning of Intermittent Hemodialysis Session
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Ratio of maximum tobramycin concentration to minimal inhibitory concentration
研究概览
简要总结
The purpose of the study is to evaluate whether the administration of a full tobramycin dose (5 mg/kg) during the first 30 minutes of a hemodialysis session provides favorable pharmacokinetic parameters in subjects with end-stage renal disease who are suspected or has been diagnosed with Gram-negative rod-type infection.
It is anticipated that the administration of a single 5 mg/kg dose of tobramycin during the first 30 minutes of a hemodialysis session will achieve an optimal ratio of maximum tobramycin concentration to minimal inhibitory concentration (Cmax/CMI) of 8 to 10 while limiting the accumulation (trough < 2 mg/L before the next hemodialysis session) in end-stage renal disease subjects requiring intermittent hemodialysis sessions.
详细描述
STUDY DESIGN:
Prospective, monocentric, non-randomized, uncontrolled pharmacokinetic study
End-stage renal disease subjects who have been involved in an intermittent hemodialysis program and who have suspected or diagnosed Gram-negative rod-type infection.
Pharmacokinetic parameters: Tobramycin concentration analyses done at the beginning of hemodialysis session (before tobramycin administration), 30 minutes after completion of the infusion (will allow us to calculate the peak), during hemodialysis session (additional), at the end of hemodialysis session, between hemodialysis sessions (optional) and just before the next hemodialysis session (will allow us to analyse the trough).
RECRUITMENT PROCESS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Subjects aged 18 and over;
- •Subjects with end-stage renal disease who are on an intermittent hemodialysis program (three times a week, 3-4 hours) at the Hôpital Maisonneuve-Rosemont hemodialysis unit for at least one month;
- •Subjects with suspicion or diagnosis of Gram-negative rod-type bacteria infection for which an antibiotic is prescribed;
- •Subjects able to consent to the study (consent form read and signed by the subject).
排除标准
- •Contraindication or possible medical hazard related to the administration of tobramycin or to any ingredient in the formulation (e.g. sulphites), such as severe allergies or aminoglycoside-reported previous intolerances;
- •Variable residual renal function (e.g. acute or transient renal failure requiring occasional hemodialysis sessions, post-renal transplantation);
- •Conditions sensitive to the side effects of tobramycin (e.g. history of myasthenia gravis, Parkinson's disease, vestibular or auditory disorder);
- •Subjects with impaired volume of distribution (ie, severe burns [> 20%], significant ascites, decompensation for acute heart failure requiring hospitalization, admission to the critical care unit, cystic fibrosis, morbid obesity [dry weight greater than 50% of ideal weight]);
- •Pregnant or breastfeeding women;
- •Unstable hemodynamic status (risk of not tolerating / completing a 3-4 hour dialysis session);
- •Recent treatment with an aminoglycoside (<1 month);
- •Participation in another research protocol;
- •Inability to give free and informed consent.
研究组 & 干预措施
Tobramycin
Subjects with end-stage renal disease who have been involved in an intermittent hemodialysis program and who have suspected or diagnosed Gram-negative rod-type infection
干预措施: Tobramycin (Drug)
结局指标
主要结局
Ratio of maximum tobramycin concentration to minimal inhibitory concentration
时间窗: The timeframe for data collection for this outcome is 48 hours to 72 hours
In subjects receiving a single 5 mg/kg tobramycin dose during the first 30 minutes of a hemodialysis session, to determine the proportion of subjects in whom the maximum concentration is greater than or equal to 8 times that of the minimal inhibitory concentration
次要结局
- Residual clearance(The timeframe for data collection for this outcome is 48 hours to 72 hours)
- Tobramycin trough level(The timeframe for data collection for this outcome is 48 hours to 72 hours)
- Clearance associated with hemodialysis(The timeframe for data collection for this outcome is 48 hours to 72 hours)
- Volume of distribution(The timeframe for data collection for this outcome is 48 hours to 72 hours)
- Total area under the curve(The timeframe for data collection for this outcome is 0 to 48 or 72 hours (depending on time between the two dialysis))
- Area under the curve between 0 to 24h after administration(The timeframe for data collection for this outcome is 0 to 24 hours)
- Tobramycin concentration(The timeframe for data collection for this outcome is 24 hours to 72 hours)
研究者
Jean-Philippe Lafrance
Principal Investigator
Maisonneuve-Rosemont Hospital