Thiamine for Coronary Artery Bypass Surgery
(B1&CABG Trial)
Recruiting in Palo Alto (17 mi)
Overseen byRajesh Kumar, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of California, Los Angeles
Must not be taking: Thiamine
Disqualifiers: Dementia, Stroke, Psychiatric diseases, others
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
12356How 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.
12356Eligibility 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.
+1 more
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
+11 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Post-CABG patients with Thiamine Treatment Intervention.Experimental Treatment1 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 Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLALos Angeles, CA
Loading ...
Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Sustained High-dose Thiamine Supplementation in High-risk Cardiac Patients Undergoing Cardiopulmonary Bypass: A Pilot Feasibility Study (The APPLY trial). [2021]To test the feasibility and investigate possible cardiovascular effects of a sustained high-dose intravenous thiamine protocol in patients undergoing combined valvular and coronary artery bypass graft surgery.
Thiamine as an adjunctive therapy in cardiac surgery: a randomized, double-blind, placebo-controlled, phase II trial. [2018]Thiamine is a vitamin that is essential for adequate aerobic metabolism. The objective of this study was to determine if thiamine administration prior to coronary artery bypass grafting would decrease post-operative lactate levels as a measure of increased aerobic metabolism.
Addition of Vitamin B Complex to Prime Solution in Cobalamin-Deficient Patients to Prevent Postoperative Delirium. [2019]In this study, we investigated whether the addition of vitamin B complex to prime solution for cardiopulmonary bypass (CPB) in cobalamin-deficient patients undergoing on-pump coronary artery bypass grafting (CABG) helps prevent the development of postoperative delirium (POD).
Thiamine levels in Indonesian children with congenital heart diseases undergoing surgery using cardiopulmonary bypass machine. [2022]This study evaluated thiamine levels in Indonesian children with congenital heart diseases before and after cardiopulmonary bypass and their relationship with clinical and surgical outcomes.
B1 Vitamin Deficiency After Bariatric Surgery, Prevalence, and Symptoms: a Systematic Review and Meta-analysis. [2022]B1 deficiency is a very prevalent complication of bariatric surgery. This study reviews prevalence and symptoms of B1 vitamin deficiency after bariatric surgery. PubMed, Scopus, and Web of Science published were searched up to 10 Feb 2022, with the following keywords: Roux-en-Y gastric bypass, one anastomosis gastric bypass, Omega bypass, Mini bypass, Bariatric surgery OR Bariatric surgery, metabolic surgery, Weight loss surgery, Classic gastric bypass, Loop gastric bypass, Gastric Bypass, thiamine OR thiamin, beriberi, B1. A total of 11 studies examining 1494 patients were included in this meta-analysis. Twenty-seven percent of patients who underwent bariatric surgeries experience vitamin B1 deficiency. Thiamine supplements should be prescribed for the patients for the rest of their lives, and also standard post-surgery follow-ups are necessary in terms of monitoring dietary factors.
A BERIBERI UNHEALTHY LATTE: ENCEPHALOPATHY AND SHOCK FROM SEVERE NUTRITIONAL DEFICIENCY. [2021]Thiamine deficiency is an uncommon cause of severe illness in the United States that can lead to significant morbidity because of high-output cardiac failure, peripheral neuropathy, and permanent neurologic impairment. We report the case of a middle-aged woman with extreme malnutrition caused by complications of Roux-en-Y gastric bypass (RYGB) surgery who presented with signs and symptoms of severe thiamine deficiency and septic shock.