Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of Individuals With Nephrotoxicity
研究概览
简要总结
For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Aged 18 years or older
- •Receiving intravenous vancomycin for the treatment of healthcare associated pneumonia, osteomyelitis/septic arthritis, endocarditis/bacteremia, or acute bacterial skin and skin structure infections
- •Expected to receive vancomycin for at least 72 hours and are within the first 72 hours of therapy
- •Have at least two or more of the following risk factors for drug-induced nephrotoxicity: a) receipt high-dose vancomycin therapy (greater than or equal to four grams per day) b) receipt of vasopressors c) receipt of nephrotoxic drugs (i.e. aminoglycosides, furosemide, acyclovir, amphotericin b, colistin, and intravenous contrast dye) d) pre-existing renal dysfunction (i.e. SCr greater than or equal to 1.5 mg/dL).
排除标准
- •Pregnancy
- •End-stage renal disease
- •Receipt of more than 4 grams of vancomycin prior to enrollment on current admission
- •Absolute neutrophil count < 1000/mm3
研究组 & 干预措施
Vancomycin
干预措施: Vancomycin (Drug)
Comparator
干预措施: Ceftaroline (Drug)
Comparator
干预措施: Daptomycin (Drug)
Comparator
干预措施: Linezolid (Drug)
结局指标
主要结局
Proportion of Individuals With Nephrotoxicity
时间窗: Day 1 and daily serum creatinine assessment up to date of discharge from hospital, and a median of 7 days.
Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days while on the study drug and through discharge from hospital. This measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group.
次要结局
- Proportion of Individuals With Acute Kidney Injury Network Modified Definition of Nephrotoxicity(Day 1 and daily serum creatinine assessment up to date of discharge, and a median of 7 days.)
- Proportion of Individuals With Clinical Success(Daily assessment of signs and symptoms of infection, and a median of 7 days.)
研究者
Jose Vazquez
M.D.
Henry Ford Health System