Short-term Atorvastatin's Effect on Acute Kidney Injury Following Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 653
- 试验地点
- 1
- 主要终点
- Number of Participants With Acute Kidney Injury
研究概览
简要总结
Aim1a: Statin naive patient's scheduled for cardiac surgery will be randomized to 80mg atorvastatin or placebo on the day prior to surgery and then 40mg daily thereafter until hospital discharge to test the hypothesis that short-term atorvastatin use decreases:
- acute kidney injury following cardiac surgery.
- postoperative delirium following cardiac surgery.
Aim1b: Patients using statins preoperatively will be randomized to atorvastatin 80mg or placebo on day of surgery and 40mg or placebo on postop day 1 with resumption of preoperative statin therapy on postop day 2 to test the hypothesis that short-term atorvastatin use decreases:
- acute kidney injury following cardiac surgery.
- postoperative delirium following cardiac surgery.
Endpoints include glomerular filtration, urine and plasma markers of renal dysfunction, markers of oxidative stress, mitochondrial function, systemic inflammatory markers, delirium, dialysis, stroke, myocardial infarction, time to extubation, ICU length of stay, and death.
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
- •open heart surgery
排除标准
- •acute coronary syndrome with troponin leak or unrelenting angina
- •liver dysfunction (transaminases 2x normal)
- •history of myopathy or liver dysfunction on prior statin therapy
- •use of potent CYP3A4 inhibitors such as antifungal azoles, macrolide antibiotics, HIV protease inhibitors, and nefazodone.
- •pregnancy or breast feeding
- •cyclosporine use
- •history of kidney transplant
- •fibrate users who cannot stop fibrate use.
研究组 & 干预措施
statin
Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.
Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1.
干预措施: atorvastatin (Drug)
placebo
Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.
Aim 2 control: placebo the day of cardiac surgery and postop day 1.
干预措施: placebo (Drug)
结局指标
主要结局
Number of Participants With Acute Kidney Injury
时间窗: postoperative day 2
Number of Participants With Delirium
时间窗: while in ICU (about 2 days)
次要结局
- Number of Participants Requiring Dialysis(while in ICU (about 2 days))
- Number of Participants With Stroke(while in ICU (about 2 days))
- Plasma Markers of Oxidative Stress: f2-Isoprostanes(anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.)
- Plasma Markers of Oxidative Stress: Isofurans(anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.)
- Plasma Markers of Inflammation: Blood Brain Barrier Disruption (S100 Calcium-binding Protein B)(anesthesia induction, ICU admission, and POD 1)
- Liver Enzyme: Aspartate Aminotransferase Level(postoperative day 1)
- Number of Participants That Died(until postoperative hospital discharge (about 7 days))
- Mitochondrial Function--mtDNA Copy Number(anesthesia induction and POD 1)
- Mitochondrial Function--lactate / Pyruvate Ratio(anesthesia induction, after CPB, and POD 1)
- Mitochondrial Function--PGC-1alpha RNA Expression(anesthesia induction and POD 1)
- Urine Markers of Oxidative Stress: f2-Isoprostanes(anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.)
- Urine Markers of Oxidative Stress: Isofurans(anesthesia induction, 30 minutes into cardiopulmonary bypass (CPB), after CPB, ICU admission, 6 hours postop, and POD 1, 2, 3.)
- Plasma Markers of Inflammation: Measurements of Neuronal Injury (Ubiquitin C-terminal Hydrolase-1)(anesthesia induction, ICU admission, and POD 1)
- Urine Markers of Renal Injury(anesthesia induction, 30 minutes into cardiopulm bypass (CPB), after CPB, ICU admission, 6 hours postop, and Post op Day (POD) 1, 2, 3)
研究者
Frederic T Billings IV
Assistant Professor of Anesthesiology and Critical Care Medicine
Vanderbilt University Medical Center