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Not yet recruitingNCT07348328PANDA XIIUpdated Jan 16, 2026

Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery

An interventional study of Compound Vitamin B tablet and Control in Cardiovascular Surgical Procedures and Major Adverse Cardiovascular Events (MACE), sponsored by Nanjing Medical University. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by Nanjing Medical University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.

02

Conditions studied

  • Cardiovascular Surgical Procedures
  • Major Adverse Cardiovascular Events (MACE)

Keywords

  • Compound Vitamin B
  • Cardiovascular Surgery
  • Major Adverse Cardiovascular Events
03

In context

Lead sponsor

Nanjing Medical University is the lead sponsor of 169 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    Vitamin B supplementation

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

    Drug: Compound Vitamin B tablet

  • Placebo comparator
    Control

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

    Drug: Control

Interventions

  • DrugCompound Vitamin B tablet

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

  • DrugControl

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

06

What researchers measure

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.

    Time frame: within 6 months after surgery between the two groups

07

Study locations

2 sites
  • Shanghai East Hospital Tongji University
    Shanghai, DR, China
  • The First Affiliated Hospital of Nanjing Medical University
    Nanjing, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07348328
Lead sponsor
Nanjing Medical University
Collaborators
The First Affiliated Hospital with Nanjing Medical University, West China Hospital, The First Affiliated Hospital of Guangzhou Medical University, The Affiliated Hospital of Qingdao University, Shanghai East Hospital
Responsible party
Hong Liu (Principal Investigator of Department of Cardiovascular Surgery, Nanjing Medical University) — Principal investigator
First posted
Jan 16, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jan 16, 2026

Study contacts

Hong Liu, MD
Contact
dr.hongliu@foxmail.com
02568303101
Guo-laing Fan, MD
Contact
smartmanliang@sina.com
Guo-liang Fan
study chair · Shanghai East Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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