Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Acute kidney injury
研究概览
简要总结
This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
详细描述
Consenting subjects meeting inclusion and exclusion will be randomized to receive melatonin 5 mg daily or a matching placebo. Study subjects will be followed for the duration of hospitalization or discontinuation of broad spectrum antibiotics (vancomycin plus piperacillin/tazobactam). The primary outcome and secondary outcomes will be evaluated by the study team.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo Arm
Placebo capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.
干预措施: Placebo Capsule (Other)
Melatonin Arm
Melatonin 5 mg capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.
干预措施: Melatonin (Drug)
结局指标
主要结局
Acute kidney injury
时间窗: From date of randomization until the date of first documented acute kidney injury or date of antibiotic discontinuation, whichever came first, assessed up to 28 days
Acute kidney injury will be defined as an increase in sCr from baseline of \>/= 0.3 mg/dL or a \>/= 50% increase from baseline.
次要结局
未报告次要终点
研究者
Luigi Brunetti
Associate Professor
Rutgers, The State University of New Jersey