TY - JOUR

T1 - Sustained High-dose Thiamine Supplementation in High-risk Cardiac Patients Undergoing Cardiopulmonary Bypass

T2 - A Pilot Feasibility Study (The APPLY trial)

AU - Lomivorotov, Vladimir V.

AU - Moroz, Gleb

AU - Ismoilov, Samandar

AU - Shmyrev, Vladimir

AU - Efremov, Sergey

AU - Abubakirov, Marat

AU - Batalov, Vasily

AU - Landoni, Giovanni

AU - Lembo, Rosalba

AU - Bogachev-Prokophiev, Alexander

AU - Sapegin, Andrey

AU - Bellomo, Rinaldo

N1 - Publisher Copyright: © 2019 Copyright: Copyright 2020 Elsevier B.V., All rights reserved.

PY - 2020/3

Y1 - 2020/3

N2 - Objective: 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. Design: Randomized, placebo-controlled, pilot feasibility trial. Setting: Cardiac surgery department of a tertiary hospital. Participants: Forty patients undergoing combined valvular and coronary artery bypass surgery. Interventions: Intravenous thiamine (600 mg on the day of surgery, and 400 mg/day on postoperative days 1, 2, and 3) or placebo. Measurements and Main Results: The 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). Conclusions: A 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.

AB - Objective: 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. Design: Randomized, placebo-controlled, pilot feasibility trial. Setting: Cardiac surgery department of a tertiary hospital. Participants: Forty patients undergoing combined valvular and coronary artery bypass surgery. Interventions: Intravenous thiamine (600 mg on the day of surgery, and 400 mg/day on postoperative days 1, 2, and 3) or placebo. Measurements and Main Results: The 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). Conclusions: A 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.

KW - cardiac index

KW - cardiopulmonary bypass

KW - feasibility

KW - mean arterial pressure

KW - open-heart surgery

KW - thiamine

KW - HEART

KW - SURGERY

KW - SEPTIC SHOCK

KW - DOUBLE-BLIND

KW - FAILURE

KW - DEFICIENCY

UR - http://www.scopus.com/inward/record.url?scp=85072401560&partnerID=8YFLogxK

U2 - 10.1053/j.jvca.2019.08.044

DO - 10.1053/j.jvca.2019.08.044

M3 - Article

C2 - 31558398

AN - SCOPUS:85072401560

VL - 34

SP - 594

EP - 600

JO - Journal of Cardiothoracic and Vascular Anesthesia

JF - Journal of Cardiothoracic and Vascular Anesthesia

SN - 1053-0770

IS - 3

ER -