Novel Urinary Biomarkers in the Detection of Vancomycin Associated Renal Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Urinary KIM-1 concentrations
研究概览
简要总结
Acute renal injury is a common complication of critical illness. Drug induced renal insult compounds the degree of injury in many patients, and a great deal of research has focused on prevention of this complication. Traditional biomarkers of renal injury like serum creatinine and blood urea nitrogen content fail to consistently predict harm among patients at risk. Kidney Injury Molecule 1 (KIM-1) will be studied as a biomarker of renal injury.
详细描述
see above
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Eligible patients are male or female adults ≥18 years of age with an expected hospital stay of at least 48 hours.
- •Eligible patients are already prescribed intravenous vancomycin or linezolid per their primary care providers as a standard of care and dosed in manner that is consistent with current institutional practices. Receipt of these antibiotics is not investigational.
排除标准
- •Exclusion criteria will include patients who have stage 3or greater Chronic Kidney Disease or who have acute kidney injury prior to the start of intravenous vancomycin therapy, patients that only receive one dose of IV vancomycin or linezolid in total, as well as patients with potentially altered pharmacokinetic parameters (pregnant patients, burn patients, and those that are morbidly obese (BMI ≥ 40 kg/m2).
- •Additionally, patients will be excluded if they are to receive more than 1 concurrent nephrotoxic medication within the prior 72 hours, have received intravenous contrast within 120 hours before randomization, exhibit baseline hematuria, or baseline proteinuria.
- •A list of concurrent nephrotoxins that would exclude patients from the study is provided in Appendix C.
- •Age Range: ≥18 years of age, if age > 90 will report as > 90 years
结局指标
主要结局
Urinary KIM-1 concentrations
时间窗: Urinary levels from day -1 to day +5, clinical outcomes and variables followed for duration of hospitalization
Urinary KIM-1 concentrations will be compared between patients receiving vancomycin and linezolid
次要结局
未报告次要终点
研究者
Marc Scheetz
Associate Professor
Midwestern University