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NCT Number: NCT07348328

Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai East Hospital Tongji University, Shanghai, DR, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Compound Vitamin B tablet

Drug

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

Control

Drug

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

Primary outcomes

  1. Compare the incidence of MACE

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guo-laing Fan, MD

CONTACT

[email protected]

Hong Liu, MD

CONTACT

[email protected]

02568303101

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

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

Registry information

Official study title

Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery: A Randomized Controlled Trial

Acronym: PANDA XII

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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