Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery

NCT07348328 | Not Yet Recruiting DMC

• 1 other identifier: PANDA XII
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cardiovascular Surgical Procedures; Major Adverse Cardiovascular Events (MACE)

Keywords

Compound Vitamin B; Cardiovascular Surgery; Major Adverse Cardiovascular Events

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vitamin B supplementation

EXPERIMENTAL

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

Drug: Compound Vitamin B tablet

Control

PLACEBO COMPARATOR

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

Drug: Control

Interventions

Compound Vitamin B tablet DRUG

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

Vitamin B supplementation

Control DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Shanghai East Hospital: collaborator
• Nanjing Medical University: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (2)

Shanghai East Hospital Tongji University

Shanghai, DR, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

Location

Study Officials

• Guo-liang Fan

  Shanghai East Hospital

  STUDY CHAIR

Central Study Contacts

Hong Liu, MD

CONTACT

02568303101; dr.hongliu@foxmail.com

Guo-laing Fan, MD

CONTACT

smartmanliang@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Department of Cardiovascular Surgery

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

CN (2)