Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Difference in serum creatinine after cardiac surgery indicating kidney injury.
研究概览
简要总结
Coenzyme Q10 (CoQ10) is an essential molecule in human body. It acts as an antioxidant, a co-factor for energy conversion in mitochondria and has anti-inflammatory effects capable of improving endothelial function. Our goal is to investigate whether CoQ10 is capable to reduce the incidence of acute kidney injury/failure following cardiac surgery. Cardiac surgery is major risk factor for acute kidney injury/failure (AKI/F).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients scheduled for elective cardiac surgery
排除标准
- •patients receiving high dose vitamin B supplementation (defined as more that 200% of recommended daily allowances)
- •patients under warfarin therapy
- •urgent surgery
- •end stage kidney disease
- •therapy with multiple nephrotoxic drugs
- •chronic kidney disease
- •obstructive uropathy
- •previous cardiac surgery procedure
- •alcohol abuse
- •malignancy
- •allergy to any ingredient of Myoqinon capsule
- •patients receiving Myoqinon and fail to demonstrate a significant increase in blood concentration of Q10
- •uncontrolled hypertension
研究组 & 干预措施
Placebo
Patients will receive per-orally placebo in three divided doses.
干预措施: Coenzyme Q10 (Dietary Supplement)
CoQ10
Patients will receive per-orally 10 mg/kg of body weight of coenzyme Q10 in the form of Myokinon (PharmaNord, Denmark) in three divided doses. They will receive therapy for at least 10 days before the surgical procedure.
干预措施: Coenzyme Q10 (Dietary Supplement)
结局指标
主要结局
Difference in serum creatinine after cardiac surgery indicating kidney injury.
时间窗: 7 days
Increase in serum creatinine as defined by KDIGO stages will be used as indicator of kidney injury.
Difference in urinary low molekular weight alpha 1 microglobulin as an indicator of kidney tubular injury.
时间窗: 3 days
Alpha 1 microglobulin is an indicator of kidney tubular damage, measured in urine.
Daily urine output during the 72 hours postoperatively.
时间窗: 3 days
Urine output less than 0.5 ml/kg/h during 6 hours indicates increased risk of developing AKI.
次要结局
- Advanced glycation endproducts(7 days)
- Length of stay in intensive care unit(10 days)
研究者
Hrvoje Vučemilović
Hrvoje Vučemilović, Principal Investigator
Clinical Hospital Center, Split