The Impact of Vitamin C on Postoperative Acute Kidney Injury in Risk Patients Undergoing Valvular Heart Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Postoperative acute kidney injury
研究概览
简要总结
In cases of cardiac surgery or sepsis which cause inflammation, oxidative stress, endothelial injury and vasoplegia, serum vitamin C concentration is sharply decreased. The anti-inflammatory and anti-oxidant effects of vitamin C and the effects of reducing vasoconstrictor use have been demonstrated in patients with sepsis and septic shock, however, the foregoing effects have not been validated in patients undergoing cardiac surgery.
In this study, investigators investigate the effect of intravenous vitamin C on the incidence of acute renal injury after valvular heart surgery.
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)
盲法说明
Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 20 years and undergoing elective valvular heart surgery whose preoperative acute renal failure score is ≥3 (moderate to severe risk).
排除标准
- •Emergency operation
- •Cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
- •Severe chronic kidney disease (GFR(CKD-EPI) <30ml/min/1.73m2)
- •Patients with past history of gout or renal stone or hyperoxaluria or cystinuria
- •Hemolytic anemia due to pyruvate kinase deficiency or glucose-6-phosphate dehydrogenase deficiency
- •Sicklemia or thalassemia
- •Hemochromatosis
- •Allergy to disodium ethylenediamine-tetraacetate or ascorbic acid
- •Patients taking aspirin up to 3 days before surgery
- •Patients taking antiepileptic drug or fluphenazine or steroid
- •Patients taking vitamin C within a month of surgery
- •Pregnant or lactating women
- •Patients who cannot understand the informed consent (eg. Foreigner)
研究组 & 干预措施
Control group
Participants in this group are administered IV normal saline.
干预措施: Control (Normal saline) (Drug)
Vitamin C group
Participants in this group are administered IV vitamin C diluted in normal saline.
干预措施: Vitamin C (Drug)
结局指标
主要结局
Postoperative acute kidney injury
时间窗: Postoperative 7 days
Compare the incidence of postoperative acute kidney injury between the Vitamin C group and the control group according to KDIGO guideline.
次要结局
- Postoperative oxidative stress and vascular injury(Comparing the serum concentration)(5 minute after CPB cessation)