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临床试验/NCT02896218
NCT02896218Unknown不适用

Therapeutic Monitoring of Vancomycin in Critical Ill Patients: a Registry

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
The rate of treatment failure

研究概览

简要总结

Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. So far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using PPK and Bayesian methods based on observed concentrations. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.

详细描述

Vancomycin is a glycopeptide antibiotic that is the first line antibiotics for the treatment of serious gram-positive infections involving methicillin-resistant Staphylococcus aureus (MRSA). Vancomycin use is associated with several adverse events, including nephrotoxicity and ototoxicity. Its therapeutic window is narrow, so there is a need to monitor serum vancomycin concentration in clinical practice, especially in the critically ill patients. Moreover, the Chinese vancomycin TDM guideline recommended that vancomycin dosage should be administered and adjusted individually based on population pharmacokinetic(PPK) and Bayesian methods. However, there is a gap between clinical practice and the guideline. So far, few studies have investigated the clinical outcomes of the dosage strategy that vancomycin dosage is administered and adjusted individually using PPK and Bayesian methods. Pharmacists could provide the vancomycin individualized dosing service by joining the ICU multidisciplinary team. The objective of this study is to investigate the effectiveness, safety and economics of the vancomycin individualized dosing service provided by pharmacists.

This is a single-center, ambispective cohort study. Patients from the retrospective and prospective cohort will be divided into 2 groups by exposure. The exposure is whether patients received pharmacists' consultation. Patients who meet the inclusion and exclusion criteria will be included in our registry. As a non-intervention study, these information as below will be collected: basic demographics, diagnosis, the initial dosage regimen and adjusted strategy of vancomycin, combined special treatment and outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Admitted to intensive care unit(ICU), Peking University Third Hospital since JAN
  • Receiving vancomycin therapy for 72 hours or more.
  • Aged ≥ 18 years.

排除标准

  • Administration of vancomycin in non-intravenous access.
  • Life expectancy of less than 24 hours.
  • Pregnancy women.
  • Presence of immunodeficiency.
  • Presence of hematological disorder.
  • Written informed consent not obtained in the prospective cohort.

结局指标

主要结局

The rate of treatment failure

时间窗: 2016-9 to 2018-1

次要结局

  • Cost-effectiveness of pharmacist intervention(2016-9 to 2018-1)
  • All cause mortality(2016-9 to 2018-1)
  • Adverse events related to vancomycin(2016-9 to 2018-1)
  • Nephrotoxicity related to vancomycin(2016-9 to 2018-1)
  • Mortality caused by infections(2016-9 to 2018-1)
  • Mortality caused by gram-positive infections(2016-9 to 2018-1)
  • Duration of using ventilator(2016-9 to 2018-1)
  • Vancomycin dosage(-2016-9 to 201)

研究者

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

Qinggang GE

M.D. Chief physician

Peking University Third Hospital

研究点 (1)

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