NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury (NACAM) Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Troponin T AUC
研究概览
简要总结
A Randomized, Double-blind, placebo-controlled Trial to Evaluate the Efficacy of Oral Nam for the Prevention of Acute Kidney Injury in Patients Undergoing On-Pump Cardiac Surgery
详细描述
This trial is a single-center, randomized, double-blind placebo-controlled Trial of Nam versus placebo in patients undergoing on-pump cardiac surgery. After screening and enrollment, patients will be stratified according to CKD status (eGFR<45 ml/min/m2) and surgical site and randomized in a 1:1 manner to receive either Nam 3 grams or placebo on the day of surgery and post-surgical days one and two.
The overall trial duration is planned for 42 months, consisting of 39 months of active recruitment and treatment period and three months of follow-up from the last patient enrolled.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oral niacinamide
干预措施: Niacinamide (Drug)
Matched placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Troponin T AUC
时间窗: From baseline to three days after surgery
Troponin T AUC, composed of single daily serum measurements
次要结局
- Mean difference in eGFR(From baseline through day 5.)
- Mean difference in uQuin/Tryp ratio AUC(From baseline to three days after surgery)