Cardiovascular Surgical ProceduresPANDA XIINCT07348328
Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery
A study testing Compound Vitamin B tablet in people with Cardiovascular Surgical Procedures and Major Adverse Cardiovascular Events (MACE), run by Nanjing Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Surgical Procedures, Major Adverse Cardiovascular Events (MACE)
- What is being tested?
- Compound Vitamin B tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Guo-laing Fan, MD contact
China2 sites
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Hong Liu, MD, 02568303101, dr.hongliu@foxmail.com
Guo-laing Fan, MD, smartmanliang@sina.com
Shanghai East Hospital Tongji University
Shanghai, DR
Guo-liang Fan, MD, 18622738357, smartmanliang@sina.com
Guo-laing Fan, MD, smartmanliang@sina.com
About this study
Official title: Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery: A Randomized Controlled 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.
- Being tested
- Compound Vitamin B tablet, Control
- Keywords
- Compound Vitamin B, Cardiovascular Surgery, Major Adverse Cardiovascular Events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Vitamin B tabletDrug
perioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery
ControlDrug
perioperative supplementation with placebo, once daily from 3 days before surgery to 6 months after surgery
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B supplementation | Experimental | perioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery Receives: Drug: Compound Vitamin B tablet |
| Control | Placebo comparator | perioperative supplementation with oral placebo, once daily from 3 days before surgery to 6 months after surgery Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 6 months after surgery between the two groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Hong Liu, Nanjing Medical University
- Investigators
- Guo-liang Fan, Study chair, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348328
- Sponsor's protocol ID
- PANDA XII
- Acronym
- PANDA XII
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin B Supplementation for Patients Undergoing Cardiovascular Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07348328
- Acronym / sponsor ID
- PANDA XII / PANDA XII
- Keywords
- Compound Vitamin B, Cardiovascular Surgery, Major Adverse Cardiovascular Events
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- 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
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin B supplementation | Experimental | Drug: Compound Vitamin B tabletperioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery |
| Control | Placebo comparator | Drug: Controlperioperative supplementation with oral placebo, once daily from 3 days before surgery to 6 months after surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound Vitamin B tabletperioperative supplementation with Compound Vitamin B tablets, once daily from 3 days before surgery to 6 months after surgery | Drug | Vitamin B supplementation |
| Controlperioperative supplementation with placebo, once daily from 3 days before surgery to 6 months after surgery | Drug | Control |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guo-laing Fan, MD contact
Guo-liang Fan study chair
Shanghai East Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compound Vitamin B tablet in people with Cardiovascular Surgical Procedures and Major Adverse Cardiovascular Events (MACE), run by Nanjing Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Liu, MD (02568303101, dr.hongliu@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the incidence of MACE (time frame: within 6 months after surgery between the two groups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.