Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Compare the incidence of MACE
研究概览
简要总结
This study is a multicenter, randomized controlled, double-blind, placebo-controlled parallel trial designed to evaluate the effect of perioperative supplementation with Compound Vitamin B on patients undergoing cardiovascular surgery. A total of 1,000 patients aged 18-80 years who are scheduled to receive cardiovascular surgeries such as coronary artery bypass grafting (CABG) and valve replacement will be enrolled. They will be randomly assigned at a 1:1 ratio to either the experimental group (perioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery) or the control group (oral placebo), with both groups receiving standardized perioperative treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 years, regardless of gender;
- •Scheduled to receive cardiovascular surgery at the research center, including coronary artery bypass grafting (CABG), cardiac valve replacement/repair, and great vessel surgery;
- •Preoperative assessment indicates that the patient is expected to complete the 6-month postoperative follow-up;
- •The patient or their authorized agent signs a written informed consent form.
排除标准
- •Regular supplementation with Compound Vitamin B (daily dose ≥ 1.5 times the recommended dietary allowance) or separate supplementation with folic acid, vitamin B6, or B12 within 3 months before surgery;
- •Severe hepatic or renal insufficiency (liver function: ALT/AST > 3 times the upper limit of normal, or total bilirubin > 2 times the upper limit of normal; renal function: serum creatinine > 265 μmol/L, or requiring long-term dialysis treatment);
- •Malignant tumors, severe hematological diseases (e.g., megaloblastic anemia, aplastic anemia), severe malnutrition (albumin < 25 g/L);
- •History of allergy to Compound Vitamin B preparations or placebo components; Pregnant women, lactating women, or those planning to become pregnant during the study period;
- •Currently participating in other interventional clinical trials;
- •Moderate to severe cognitive impairment without a fixed caregiver, unable to cooperate with treatment and follow-up;
- •Preoperatively diagnosed with severe infection, septicemia, or septic shock.
研究组 & 干预措施
Vitamin B supplementation
perioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery
干预措施: Compound Vitamin B tablet (Drug)
Control
perioperative supplementation with oral placebo, once daily from 3 days before surgery to 6 months after surgery
干预措施: Control (Drug)
结局指标
主要结局
Compare the incidence of MACE
时间窗: within 6 months after surgery between the two groups
MACE is defined as a composite endpoint, including: cardiac death, non-fatal myocardial infarction (postoperative troponin peak \> 10 times the upper limit of normal accompanied by chest pain and dynamic changes in electrocardiogram), ischemic stroke (new-onset neurological deficits after surgery confirmed by cranial CT/MRI), severe arrhythmia (sustained ventricular tachycardia, ventricular fibrillation, third-degree atrioventricular block requiring implantation of a temporary/permanent pacemaker), and readmission due to cardiac causes.
次要结局
未报告次要终点
研究者
Hong Liu
Principal Investigator of Department of Cardiovascular Surgery
Nanjing Medical University