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Not yet recruiting NCT07348328

Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery

No phase Interventional Cardiovascular Surgical Procedures Major Adverse Cardiovascular Events (MACE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Compound Vitamin B tablet, Control.
Who it may be relevant to
Registry conditions: Cardiovascular Surgical Procedures, Major Adverse Cardiovascular Events (MACE). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Compare the incidence of MACE [Time frame: within 6 months after surgery between the two groups]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 2 centers
  • Shanghai East Hospital Tongji University — Shanghai
  • The First Affiliated Hospital of Nanjing Medical University — Nanjing

Identifiers

NCT: NCT07348328 · PANDA XII

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗