Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNanjing Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Compound Vitamin B tablet
Drugperioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery
Control
Drugperioperative supplementation with placebo, once daily from 3 days before surgery to 6 months after surgery
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Vitamin B supplementationExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
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 groupsSponsors and contacts
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Nanjing Medical University
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
West China Hospital
Collaborator
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Shanghai East Hospital
Collaborator
Source ClinicalTrials.gov
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