跳至主要内容
临床试验/NCT03507751
NCT03507751已完成不适用

Pharmacokinetics of Meropenem During High-dose Continuous Renal Replacement Therapy in Critically Ill Patients

Medical University of Lublin1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年4月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Plasma concentration of meropenem

研究概览

简要总结

Assessment of meropenem plasma concentration in critically ill patients who require CRRT (continuous renal replacement therapy). A standard dose of meropenem is administered, i.e. 1 gram every 8 hours.

详细描述

This is a prospective observational study performed on critically ill patients. Inclusion criteria are a severe infection on admission requiring the use of meropenem and CRRT.

Both medical and surgical patients will be included. Any type of infections can be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes one-hour infusion of meropenem (1.0 gram) intravenously every 8 hours.

Blood samples (2 mL) will be collected at the 15, 30, 45, 60, 75, 90, 120, 180, 240, and 480 minutes after each dose of meropenem for 3 consecutive days. The standard arterial canula will be used to obtain samples.

30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.

Serum meropenem concentration will be measured by high-performance liquid chromatography.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who require ICU treatment due to severe infection
  • age 18-80 years
  • an eligible consent obtained from the patient or his/her attendant

排除标准

  • allergy to meropenem
  • lack of consent to participate in the study
  • age of patients below 18 or above 80 years

研究组 & 干预措施

Meropenem

Patients who require meropenem and CRRT during ICU (intensive care unit) stay

干预措施: Meropenem (Drug)

Meropenem

Patients who require meropenem and CRRT during ICU (intensive care unit) stay

干预措施: CRRT (Device)

结局指标

主要结局

Plasma concentration of meropenem

时间窗: 3 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michał Borys

M.D., Ph.D.

Medical University of Lublin

研究点 (1)

Loading locations...

相似试验

Pharmacokinetics of Meropenem During High-dose CRRT | 临床试验