Thiamine for Coronary Artery Bypass Surgery

(B1&CABG Trial)

Overseen By Dineth Karunamuni, MS

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if thiamine, a low-cost vitamin, can reduce memory and thinking problems after heart surgery, specifically coronary artery bypass grafting (CABG). Researchers will compare patients receiving thiamine with those who do not to identify any differences in cognitive health and related blood markers. Suitable candidates have coronary heart disease, are scheduled for CABG, and have low thiamine levels. As an Early Phase 1 trial, this research focuses on understanding thiamine's effects in people, offering participants a chance to contribute to groundbreaking insights.

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.

Is there any evidence suggesting that thiamine is likely to be safe for humans?

Research has shown that thiamine, or Vitamin B1, is generally safe during heart surgery. One study found that patients who received high doses of thiamine during heart surgery tolerated it well, with no major safety issues. Some studies also suggest that thiamine, when combined with Vitamin C, can help reduce inflammation and heart muscle damage. However, since this trial is in an early stage, it primarily explores how thiamine might improve brain function after heart surgery and its safety in this specific context. This phase usually involves smaller patient groups, so more information is needed about its safety and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for post-CABG recovery, which typically focus on managing cardiovascular health and reducing complications, thiamine is being explored for its potential cognitive benefits. Researchers are excited about thiamine because it's a vitamin that could improve brain function and reduce inflammation after surgery. While many treatments target heart function and circulation, thiamine works differently by potentially enhancing cognitive recovery and lowering levels of lactate and inflammatory markers, which are vital for overall healing. This approach could offer a new way to support patients' recovery beyond the traditional focus on heart health alone.

What evidence suggests that thiamine might be an effective treatment for post-CABG cognitive issues?

Research has shown that thiamine, or vitamin B1, might benefit individuals undergoing coronary artery bypass surgery (CABG). Thiamine levels often drop significantly after this surgery, potentially leading to issues like elevated lactate levels that can hinder recovery. Some studies suggest that taking thiamine before surgery can help reduce these lactate levels. This trial will compare post-CABG patients receiving thiamine treatment with those receiving a placebo to assess its impact on recovery and cognitive function. Although more research is needed, thiamine appears to be a promising and affordable option for aiding recovery after CABG. ^{1 4 6 7 8}

Who Is on the Research Team?

Rajesh Kumar, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4820988/

Thiamine as an adjunctive therapy in cardiac surgery The objective of this study was to determine if thiamine administration prior to coronary artery bypass grafting would decrease post-operative lactate levels.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900709002500

Coronary artery bypass graft surgery depletes plasma ... Plasma thiamine levels decreased significantly from before to after coronary artery bypass grafting (P = 0.0004). In addition, there was a statistically ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06326996

Thiamine Intervention and Coronary Artery Bypass Grafting This clinical trial study will provide required data regarding the benefits of a low-cost thiamine intervention that could be implemented on a large-scale ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2874825/

Coronary Artery Bypass Graft (CABG) surgery depletes ... Specifically, we found a statistically significant drop in thiamine levels from pre- to immediately post-CABG surgery. In addition, there was a statistically ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02322892

Thiamine as an Adjunctive Therapy in Cardiac Surgery The main purpose of this pilot study is to test the effects of thiamine (vitamin B1) administration before and after major cardiac surgery. Half of patients ...

6. jcvaonline.com jcvaonline.com/article/S1053-0770(19)31126-7/fulltext

Thiamine – Essential Post Cardiopulmonary Bypass? Vitamin B1 thiamine deficiency (Beriberi)​​ Patients undergoing cardiac surgery are at increased risk of thiamine deficiency.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11944524/

Effect of Combined Vitamin C and Thiamine Therapy on ... In this study, the addition of vitamin B1 to vitamin C significantly attenuated myocardial injury and immediate postoperative inflammatory responses, as ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1053077019309115

Sustained High-dose Thiamine Supplementation in ... A double-blind trial of sustained high-dose intravenous thiamine supplementation in higher-risk cardiac surgery patients was feasible and appeared to be safe.