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| Name | Class |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| West China Hospital | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin B supplementation | Experimental | perioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery |
|
| Control | Placebo Comparator | perioperative supplementation with oral placebo, once daily from 3 days before surgery to 6 months after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Vitamin B tablet | Drug | perioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the incidence of MACE | 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. | within 6 months after surgery between the two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Liu, MD | Contact | 02568303101 | dr.hongliu@foxmail.com | |
| Guo-laing Fan, MD | Contact | smartmanliang@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Guo-liang Fan | Shanghai East Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital Tongji University | Shanghai | DR | China |
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| The Affiliated Hospital of Qingdao University |
| OTHER |
| Shanghai East Hospital | OTHER |
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| Control | Drug | perioperative supplementation with placebo, once daily from 3 days before surgery to 6 months after surgery |
|
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | China |
|