Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Cardiovascular Surgical Procedures Major Adverse Cardiovascular Events (MACE)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin B supplementation

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

Group Type EXPERIMENTAL

Compound Vitamin B tablet

Intervention Type DRUG

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

Control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

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

Interventions

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Compound Vitamin B tablet

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

Intervention Type DRUG

Control

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No