• J. Cardiothorac. Vasc. Anesth. · Mar 2020

    Randomized Controlled Trial

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

    • Vladimir V Lomivorotov, Gleb Moroz, Samandar Ismoilov, Vladimir Shmyrev, Sergey Efremov, Marat Abubakirov, Vasily Batalov, Giovanni Landoni, Rosalba Lembo, Alexander Bogachev-Prokophiev, Andrey Sapegin, and Rinaldo Bellomo.
    • E. Meshalkin National Medical Research Center, Novosibirsk, Russia; Novosibirsk State University, Novosibirsk, Russia. Electronic address: vvlom@mail.ru.
    • J. Cardiothorac. Vasc. Anesth. 2020 Mar 1; 34 (3): 594-600.

    ObjectiveTo 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.DesignRandomized, placebo-controlled, pilot feasibility trial.SettingCardiac surgery department of a tertiary hospital.ParticipantsForty patients undergoing combined valvular and coronary artery bypass surgery.InterventionsIntravenous thiamine (600 mg on the day of surgery, and 400 mg/day on postoperative days 1, 2, and 3) or placebo.Measurements And Main ResultsThe primary feasibility endpoints were recruitment rate and protocol compliance. Secondary endpoints included markers of possible biological and physiological effects. The mean recruitment rate was 8 patients per month and protocol compliance was 97.5%. There were no differences in median peak postoperative lactate (2.7 mmol/L [interquartile range [IQR] 1.4-4.6] for thiamine v 2.5 mmol/L [IQR 1.4-3.6] for placebo; p = 0.53), median peak postoperative creatinine (104 µmol/L [IQR 92.5-129] for thiamine v 99 µmol/L [IQR 86.5-109.5] for placebo; p = 0.53), median nadir postoperative cardiac index (1.8 L/min/m2 [IQR 1.5-2.1] for thiamine v 2.2 L/min/m2 [IQR 1.5-2.5] for placebo; p = 0.25), or the number of patients on vasopressor/inotropic agents (thiamine, 12 [63%]; placebo, 12 [60%]; p = 0.80), or in the total inotrope/vasopressor dose 0.14 µg/kg for thiamine v 0.12 µg/kg for placebo; p = 0.88).ConclusionsA double-blind trial of sustained high-dose intravenous thiamine supplementation in higher-risk cardiac surgery patients was feasible and appeared to be safe. However, such treatment did not demonstrate evidence of biological or physiological effects.Crown Copyright © 2019. Published by Elsevier Inc. All rights reserved.

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