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临床试验/NCT02945241
NCT02945241已完成1 期

Impact of Cystatin-C C-guided Vancomycin Dosing Recommendation on Target Trough Achievement and Clinical Outcomes in Critically Ill Adults

Mayo Clinic0 个研究点目标入组 399 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Mayo Clinic
入组人数
399
主要终点
Vancomycin target trough achievement

研究概览

简要总结

Determine if a cystatin C-inclusive vancomycin dosing algorithm improved target trough achievement compared to creatinine clearance-guided vancomycin therapy in critically ill patients.

详细描述

This is a prospective, quality improvement study that evaluated critically ill patients initiated on intravenous vancomycin. Between January 2012 through October 2013, vancomycin was dosed at 15-20mg/kg at an interval guided by creatinine clearance using the Cockcroft Gault equation (control arm). Steady state trough concentrations were assessed prior to the 4th dose of a consistent regimen and compared to the individualized target trough range (10-15mg/L or 15-20mg/L) appropriate for the suspected or documented source of infection. Given low overall trough achievement observed with standard care, a quality improvement project was undertaken. After approval by local clinical practice committees with representation from the Division of Infectious Diseases, Pharmacy and Critical Care, a quality improvement project was undertaken to implement a new vancomycin dosing nomogram with dosing intervals based on the Chronic Kidney Disease Epidemiology Collaborative (CKD-EPI) creatinine-cystatin GFR equation, expressed in mL/min. After structured education was provided, the dosing algorithm was rolled out from December 2013 through May 2015 (intervention arm). Steady state target vancomycin trough achievement was compared between study arms with and without adjustment for potential confounders.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Hospitalized in one of three intensive care units at Mayo Clinic in Rochester, Minnesota
  • Suspected or documented gram-positive infection
  • Prescribed IV vancomycin at a consistent dose and scheduled with 8, 12, or 24 hour Vancomycin dosing interval

排除标准

  • Vulnerable population
  • Received greater than 1 dose of Vancomycin in the 96 hours before ICU admission
  • Baseline glomerular filtration rate (GFR) of less than 20 milliliters/minute
  • Undergoing renal replacement therapy
  • Body mass index > 40kg/m2
  • Weight < 40kg

研究组 & 干预措施

Cystatin C-guided vancomycin dosing algorithm

Experimental

Cystatin C is an endogenous cysteine proteinase inhibitor produced by all nucleated cells and a biomarker used routinely to estimate glomerular filtration rate either alone or in combination with creatinine. This new dosing algorithm includes patient weight, individualized goal trough concentration, and glomerular filtration rate (expressed with the CKD-EPI creatinine-cystatin C equation in mL/min) to determine dose and frequency.

干预措施: Vancomycin (Drug)

Cystatin C-guided vancomycin dosing algorithm

Experimental

Cystatin C is an endogenous cysteine proteinase inhibitor produced by all nucleated cells and a biomarker used routinely to estimate glomerular filtration rate either alone or in combination with creatinine. This new dosing algorithm includes patient weight, individualized goal trough concentration, and glomerular filtration rate (expressed with the CKD-EPI creatinine-cystatin C equation in mL/min) to determine dose and frequency.

干预措施: Cystatin C dosing algorithm (Other)

Creatinine clearance guided vancomycin dosing

Other

Historical controls for the quality improvement project had doses based on weight and interval established with the creatinine clearance using the Cockcroft-Gault equation.

干预措施: Vancomycin (Drug)

Creatinine clearance guided vancomycin dosing

Other

Historical controls for the quality improvement project had doses based on weight and interval established with the creatinine clearance using the Cockcroft-Gault equation.

干预措施: Creatine clearance dosing algorithm (Other)

结局指标

主要结局

Vancomycin target trough achievement

时间窗: Baseline

The percentage of initial steady state troughs within the target range.

次要结局

  • Length of stay (hospital and ICU)(Baseline)
  • Treatment failure(7-days)
  • Infection recurrence(28-days)
  • Acute kidney injury (AKI) and renal replacement therapy(7-days)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erin Barreto

Assistant Professor of Pharmacy and Medicine

Mayo Clinic

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