NAD Supplementation to Reduce the Incidence of Cardiac Surgery Associated Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Post Operative day 1 urinary KIM-1
研究概览
简要总结
The purpose of this single-center, randomized, double-blinded placebo-controlled pilot trial is to demonstrate feasibility and help design a larger trial to assess the effectiveness of nicotinamide (NAM) supplementation in reducing risk of post-operative AKI in patients undergoing cardiac surgery.
详细描述
This single-center, randomized, double-blind, placebo-controlled trial will serve as a pilot for a larger study that aims to assess the efficacy of nicotinamide in reducing ischemia-reperfusion injury and acute kidney injury (AKI) in patients undergoing cardiac surgery. A total of 20 patients will be randomized in a 1:1 ratio to receive either a one-time dose of NAM 3000 mg or a matching placebo on the morning of surgery. Safety assessments and clinical outcomes will be monitored for 2 days (> 5 half-lives) . Blood samples will be collected from patients at up to two time points: preoperatively (after insertion of an arterial line [for blood] and intraoperatively at the end of CPB. Urine samples will also be collected at two timepoints: after insertion of the foley catheter but prior to incision, and on the morning of post-operative day 1. Discarded tissue specimens will be collected from patients at two time points: initially when excised pre-bypass, and another post-bypass, depending on the tissue availability and as a regular part of the surgery. Time points will be recorded for all the collections.
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
- •Age ≥18 years
- •Undergoing coronary artery bypass graft (CABG) and/or valve surgery with cardiopulmonary bypass (CPB) at BIDMC. Includes combination surgeries that involve CABG and/or valve plus other procedures (e.g., Maze procedure, aortic aneurysm repair).
- •AKI risk score ≥6 at the time of screening
排除标准
- •History of AKI in the seven days prior to surgery, defined as any of the following:
- •Increase in serum creatinine ≥0.3 mg/dl in 48h
- •Increase in serum creatinine ≥50% in 7d (if no value available in last 7d, use most recent value in last 3 months)
- •Urine output ≤0.5 ml/kg/h x 6 consecutive hours (only assessed in patients with hourly monitoring via Foley catheter)
- •Receipt of renal replacement therapy (RRT) within 7d
- •Advanced chronic kidney disease (eGFR <15 ml/min/1.73m2 or end-stage kidney disease receiving RRT)
- •Pregnant or breastfeeding*
- •Positive COVID test in the last 10 days.
- •Prisoner or institutionalized
- •Existing or anticipated durable VAD
- •8. Conflict with other studies
- •9. Previous usage of nicotinamide supplements in the past 30 days
结局指标
主要结局
Post Operative day 1 urinary KIM-1
时间窗: From enrollment to 1 day post cardiac surgery
Measurement of urinary KIM-1 pre-bypass and on post-operative day 1 compared via t-test.
次要结局
未报告次要终点
研究者
Mark Robitaille
Principal Investigator
Beth Israel Deaconess Medical Center