Thiamine for Coronary Artery Bypass Surgery

(B1&CABG Trial)

Overseen By Bhaswati Roy, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Los Angeles

Must not be taking: Thiamine

Disqualifiers: Dementia, Stroke, Psychiatric diseases, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 month

52 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking thiamine.

What data supports the effectiveness of the drug Thiamine (Vitamin B1) for coronary artery bypass surgery?

Research suggests that thiamine may help improve heart function during surgery by enhancing aerobic metabolism, which is how the body uses oxygen to produce energy. Another study indicates that thiamine could reduce post-operative complications like high lactate levels, which are linked to better recovery after heart surgery. ^{1 2 3 4 5}

Is thiamine safe for use in humans, especially in the context of coronary artery bypass surgery?

Thiamine (Vitamin B1) is generally considered safe for use in humans, including in high-risk cardiac patients undergoing coronary artery bypass surgery, as shown in studies where it was used without significant safety concerns. ^{1 2 3 5 6}

How is the drug Thiamine unique for coronary artery bypass surgery?

Thiamine (Vitamin B1) is unique for coronary artery bypass surgery because it is used to enhance aerobic metabolism, potentially reducing post-operative lactate levels, which is not a standard approach in this context. Unlike typical treatments that focus on surgical techniques or medications to manage heart function, Thiamine aims to improve the body's energy production during and after surgery. ^{1 2 3 5 6}

What is the purpose of this trial?

The purpose of this study is to gain a better understanding of the association between brain changes and cognitive deficits in coronary heart disease (CHD) patients undergoing coronary artery bypass grafting (CABG) and whether a low-cost thiamine intervention can be used to reduce post-CABG cognitive issues in CHD subjects.

Research Team

Rajesh Kumar, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for individuals with coronary heart disease who are scheduled to undergo coronary artery bypass grafting (CABG). Participants should be interested in exploring if thiamine can help reduce cognitive issues after surgery.

Inclusion Criteria

My heart surgery will be done without stopping my heart.

European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) >1.5%

I have heart disease and am scheduled for a bypass operation.

Exclusion Criteria

Recent cerebral incidents (seizure or head trauma resulting in loss of consciousness and/or concussion within several years and/or up to the judgment of the PI/co-PIs)

Dementia at baseline (Montreal Cognitive Assessment (MoCA) <21 within 5 days before CABG)

Known thiamine allergy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive thiamine or placebo treatment and undergo cognitive assessments and blood evaluations

1 month

2 visits (in-person)

Follow-up

Participants are monitored for long-term effects on cognition, daily activities, and quality of life

6 months

1 visit (in-person)

Treatment Details

Interventions

• Thiamine

Trial Overview The study is testing whether taking thiamine, a vitamin B1 supplement, compared to a placebo (a substance with no active drug), can improve brain function and reduce cognitive deficits after CABG surgery in patients with CHD.

Participant Groups

Group I: Post-CABG patients with Thiamine Treatment Intervention. Experimental Treatment 1 Intervention

Assess cognition and evaluate blood thiamine, lactate, and inflammatory marker levels in patients receiving thiamine intervention treatment within 5 days (baseline) and one month after CABG.

Group II: Post-CABG patients without Thiamine Treatment Intervention. Placebo Group 1 Intervention

Assess cognition and evaluate blood thiamine, lactate, and inflammatory marker levels in patients receiving placebo treatment within 5 days (baseline) and one month after CABG.

Thiamine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Thiamine for:

• Thiamine deficiency
• Beriberi
• Wernicke-Korsakoff syndrome

Approved in European Union as Thiamine for:

• Thiamine deficiency
• Beriberi
• Wernicke-Korsakoff syndrome

Approved in Canada as Thiamine for:

• Thiamine deficiency
• Beriberi
• Wernicke-Korsakoff syndrome

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

A pilot study involving 40 patients undergoing cardiac surgery showed that high-dose intravenous thiamine supplementation was feasible and safe, with a high protocol compliance rate of 97.5%.

Despite the safety and feasibility, the study found no significant biological or physiological effects of thiamine on postoperative markers such as lactate, creatinine, or cardiac index compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained High-dose Thiamine Supplementation in High-risk Cardiac Patients Undergoing Cardiopulmonary Bypass: A Pilot Feasibility Study (The APPLY trial). Lomivorotov, VV., Moroz, G., Ismoilov, S., et al.[2021]

Thiamine administration before coronary artery bypass grafting significantly increased thiamine levels and post-operative global oxygen consumption, indicating enhanced aerobic metabolism.

However, there was no difference in post-operative lactate levels or clinical outcomes between the thiamine and placebo groups, suggesting that while thiamine may improve oxygen consumption, it does not impact lactate levels or overall recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thiamine as an adjunctive therapy in cardiac surgery: a randomized, double-blind, placebo-controlled, phase II trial. Andersen, LW., Holmberg, MJ., Berg, KM., et al.[2018]

In a study of 138 cobalamin-deficient patients undergoing coronary artery bypass grafting, adding vitamin B complex to the cardiopulmonary bypass solution significantly reduced the incidence of postoperative delirium (POD) from 42% in the control group to 26% in the vitamin B group (P = .017).

The study also found that vitamin B complex acted as an independent protective factor against POD, with a logistic regression analysis showing an odds ratio of 0.23, indicating a strong association between vitamin B supplementation and reduced delirium severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of Vitamin B Complex to Prime Solution in Cobalamin-Deficient Patients to Prevent Postoperative Delirium. Demirdas, E., Atilgan, K.[2019]

In a study of 25 Indonesian children undergoing surgery for congenital heart diseases, thiamine levels remained stable before and after cardiopulmonary bypass, indicating that the surgery did not significantly affect thiamine levels overall.

However, longer durations of cardiopulmonary bypass were associated with a significant reduction in thiamine levels, although this decrease did not correlate with clinical outcomes, suggesting that thiamine levels may not be a critical factor in surgical recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thiamine levels in Indonesian children with congenital heart diseases undergoing surgery using cardiopulmonary bypass machine. Marwali, EM., Caesa, P., Purnama, Y., et al.[2022]

About 27% of patients who undergo bariatric surgery experience a deficiency in vitamin B1 (thiamine), highlighting a significant risk associated with these procedures.

To prevent and manage this deficiency, lifelong thiamine supplementation and regular dietary monitoring are essential for patients after bariatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

B1 Vitamin Deficiency After Bariatric Surgery, Prevalence, and Symptoms: a Systematic Review and Meta-analysis. Bahardoust, M., Eghbali, F., Shahmiri, SS., et al.[2022]

A case study of a 43-year-old woman with severe thiamine deficiency due to malnutrition after Roux-en-Y gastric bypass surgery demonstrated that high-dose thiamine treatment can rapidly reverse symptoms of shock, heart failure, and encephalopathy.

Thiamine deficiency, although rare, is a reversible condition that can lead to serious health issues; recognizing at-risk patients allows for timely intervention with vitamin B1, which can significantly improve outcomes like mortality and hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A BERIBERI UNHEALTHY LATTE: ENCEPHALOPATHY AND SHOCK FROM SEVERE NUTRITIONAL DEFICIENCY. Self, M., Signorelli, J., Lasoff, D., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sustained High-dose Thiamine Supplementation in High-risk Cardiac Patients Undergoing Cardiopulmonary Bypass: A Pilot Feasibility Study (The APPLY trial). [2021]

2. England pubmed.ncbi.nlm.nih.gov

Thiamine as an adjunctive therapy in cardiac surgery: a randomized, double-blind, placebo-controlled, phase II trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Addition of Vitamin B Complex to Prime Solution in Cobalamin-Deficient Patients to Prevent Postoperative Delirium. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Thiamine levels in Indonesian children with congenital heart diseases undergoing surgery using cardiopulmonary bypass machine. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

B1 Vitamin Deficiency After Bariatric Surgery, Prevalence, and Symptoms: a Systematic Review and Meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A BERIBERI UNHEALTHY LATTE: ENCEPHALOPATHY AND SHOCK FROM SEVERE NUTRITIONAL DEFICIENCY. [2021]