Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery

NCT07348328 · tracked via the Priya Life Science China tracker

Sponsor

Nanjing Medical University

Phase

Not applicable

Started

2026-02-01

Last updated

2026-01-16

Condition(s) studied

Cardiovascular Surgical ProceduresMajor Adverse Cardiovascular Events (MACE)

Investigational drug(s) / intervention(s)

Compound Vitamin B tabletControl

Compound Vitamin B tablet: perioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery

Control: perioperative supplementation with placebo, once daily from 3 days before surgery to 6 months after surgery

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Compare the incidence of MACE — 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.

Trial sites (2)

Facility	City	Region	Status
Shanghai East Hospital Tongji University	Shanghai	DR
The First Affiliated Hospital of Nanjing Medical University	Nanjing	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07348328 on ClinicalTrials.gov ↗ ← All trials in China