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

Ломиворотов, В. В.; Мороз, Г. Б.; Ismoilov, Samandar; Shmyrev, Vladimir; Efremov, Sergey; Abubakirov, Marat; Batalov, Vasily; Landoni, Giovanni; Lembo, Rosalba; Bogachev-Prokophiev, Alexander; Сапегин, А. В.; Bellomo, Rinaldo

doi:10.1053/j.jvca.2019.08.044

Cited by 8 publications

(9 citation statements)

References 18 publications

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“…An interesting phenomenon was observed in Anderson et al whereby patients who received thiamine supplementation had reduced PDH activity [12]. Lomivorotov et al recently performed a pilot feasibility trial of thiamine supplementation in patients undergoing CPB and noted a trend toward higher lactate levels in the first 24 h post-operatively in those who received thiamine supplementation [14]. Biological plausibility would support that reduced PDH activity would correlate with higher lactate levels, but the mechanism by which thiamine supplementation would be associated with reduced PDH activity is uncertain.…”

Section: Discussionmentioning

confidence: 90%

“…Based on the apparent CPB-related thiamine depletion demonstrated in previous research, numerous RCTs have been undertaken whereby thiamine is administered to patients undergoing CPB [10][11][12][13][14]. No RCT has shown that thiamine supplementation has significant effect on post-operative lactate levels or other outcome measures, though studies have been under-powered to detect such effects [12][13][14]. If nothing else, the results of this study highlight the need for careful re-consideration of the use of resources regarding future research into this area.…”

Section: Discussionmentioning

confidence: 99%

“…Additionally, one study identified an inverse relationship between thiamine levels and lactate levels [11]. Based on these two studies demonstrating post-CPB thiamine depletion, multiple randomized control trials (RCT) have analysed the effects of thiamine administration on post-operative lactate levels in patients undergoing CPB, compared with placebo [12][13][14]. While no RCT has shown a statistically significant effect of thiamine supplementation on post-operative lactate level, studies performed to date have been underpowered to detect this effect [12][13][14].…”

Section: Introductionmentioning

confidence: 99%

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The effect of cardiopulmonary bypass on blood thiamine concentration and its association with post-operative lactate concentration

Odelli

Holyoak²,

Yadav

et al. 2022

J Cardiothorac Surg

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Objective Cardiothoracic surgery is a large field in Australia, and evidence suggests post-cardiopulmonary bypass (CPB) hyperlactataemia is associated with higher morbidity and mortality. Low thiamine levels are a potentially common yet treatable cause of hyperlactataemia and may occur in the setting of exposure to CPB non-biological material. We hypothesized that cardiopulmonary bypass would result in decreased whole-blood thiamine levels, which may therefore result in increased whole-blood lactate levels in the post-operative period. Methods Adult patients undergoing non-emergent CPB were recruited in a single centre, prospective, analytic observational study at Townsville University Hospital, Australia. The primary outcome was a comparison of pre- and post-CPB thiamine diphosphate level, secondarily aiming to assess any relationship between lactate and thiamine levels. Prospective pre- and post-CPB blood samples were taken and analysed at a central reference laboratory. Results Data was available for analysis on 78 patients. There was a statistically significant increase in thiamine diphosphate level from pre-CPB: 1.36 nmol/g Hb, standard deviation (SD) 0.31, 95% confidence intervals (CI) 1.29–1.43, to post-CPB: 1.77 nmol/g Hb, SD 0.53, 95% CI 1.43–1.88, p value < 0.001. There was a non-statistically significant (p > 0.05) trend in rising whole-blood lactate levels with increasing time. Analysis of lactate levels at varying time periods found a significant difference between baseline measurements and increased levels at 13–16 h (p < 0.05). There was no significant relationship observed between whole-blood thiamine levels and post-operative lactate levels. Conclusion Whole-blood thiamine levels were found to increase immediately post-CPB in those undergoing elective cardiac surgery. There was no correlation between whole-blood thiamine levels and post-operative arterial lactate levels.

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Section: Discussionmentioning

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The effect of cardiopulmonary bypass on blood thiamine concentration and its association with post-operative lactate concentration

Odelli

Holyoak²,

Yadav

et al. 2022

J Cardiothorac Surg

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“…However, a recent observational study found, in a nationwide database investigation, no results that supported an association between an early thiamine administration dose after admission and 28-day mortality [ 8 ]. To date, clinical evidence outcomes of thiamine remain inconsistent, and thiamine doses of 400 mg per day appear to be safe in clinical trials and may reduce lactate clearance [ 9 , 10 ]. We hypothesized that thiamine administration in patients with septic shock would decrease vasopressor requirements and organ failure compared with the corresponding outcomes in patients who did not receive thiamine; this was based on the hypothesized role of thiamine as a metabolic resuscitator.…”

Section: Introductionmentioning

confidence: 99%

Effects of thiamine on vasopressor requirements in patients with septic shock: a prospective randomized controlled trial

et al. 2020

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Background Thiamine, an essential vitamin for aerobic metabolism and glutathione cycling, may decrease the effects of critical illnesses. The objective of this study was to determine whether intravenous thiamine administration can reduce vasopressor requirements in patients with septic shock. Methods This study was a prospective randomized double-blind placebo-controlled trial. We included adult patients with septic shock who required a vasopressor within 1–24 h after admission between March 2018 and January 2019 at a tertiary hospital in Thailand. Patients were divided into two groups: those who received 200 mg thiamine or those receiving a placebo every 12 h for 7 days or until hospital discharge. The primary outcome was the number of vasopressor-free days over 7 days. The pre-defined sample size was 31 patients per group, and the study was terminated early due to difficult recruitment. Results Sixty-two patients were screened and 50 patients were finally enrolled in the study, 25 in each group. There was no difference in the primary outcome of vasopressor-free days within the 7-day period between the thiamine and placebo groups (mean: 4.9 days (1.9) vs. 4.0 days (2.7), p = 0.197, mean difference − 0.9, 95% CI (− 2.9 to 0.5)). However, the reductions in lactate (p = 0.024) and in the vasopressor dependency index (p = 0.02) at 24 h were greater among subjects who received thiamine repletion vs. the placebo. No statistically significant difference was observed in SOFA scores within 7 days, vasopressor dependency index within 4 days and 7 days, or 28-day mortality. Conclusions Thiamine was not associated to a significant reduction in vasopressor-free days over 7-days in comparison to placebo in patients with septic shock. Administration of thiamine could be associated with a reduction in vasopressor dependency index and lactate level within 24 h. The study is limited by early stopping and low sample size. Trial registration TCTR, TCTR20180310001. Registered 8 March 2018, http://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=3330.

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“…IN THIS ISSUE of the Journal of Cardiothoracic and Vascular Anesthesia, Lomivorotov et al report the findings of APPLY (sustAined high-dose thiamine supplementation in high-risk cardiac patients undergoing cardiopulmonarY bypass: a pilot feasibility study), a pilot randomized controlled trial (RCT) designed to assess the feasibility of perioperative thiamine therapy to improve cardiovascular function in patients undergoing cardiac bypass surgery. 1 The proposal is intriguing, not least because the candidate intervention is relatively cheap, safe, simple to administer, and there is a clear and well-established chain of causality between severe thiamine deficiency and cardiac dysfunction.…”

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confidence: 99%

Thiamine – Essential Post Cardiopulmonary Bypass?

Wenger

Litton

2020

Journal of Cardiothoracic and Vascular Anesthesia

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

Cited by 8 publications

References 18 publications

The effect of cardiopulmonary bypass on blood thiamine concentration and its association with post-operative lactate concentration

The effect of cardiopulmonary bypass on blood thiamine concentration and its association with post-operative lactate concentration

Effects of thiamine on vasopressor requirements in patients with septic shock: a prospective randomized controlled trial

Thiamine – Essential Post Cardiopulmonary Bypass?

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