Is Thiamine Administration Effective in Sepsis or Not? A Randomized Controlled Trial
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Abstract
Background: Sepsis is the first leading cause of death in Myanmar and complications are also difficult to solve. This study aimed to detect the effect of thiamine on lactate clearance and mortality in patients with sepsis.
Method: A randomized controlled trial done in No.(1) Defence Services General Hospital, Yangon from October 2020 to June 2022. All patients > 18 years old admitted with suspected or documented infection and qSOFA score 2 or 3 were included but alcohol related cases were excluded. Total 80 patients were assigned 1:1 by block randomization. Intervention group was given IV thiamine 100 mg 6 hourly for 3 days. Primary outcome was lactate clearance and secondary outcomes, mSOFA score (both were assessed in day 1, day 3 and day 7), and mortality within 7 days. Intention to treat analysis with worst data imputation in missing value for expired cases.
Results: Significant lactate clearance was seen in intervention group compared with control group, in day 3, [23.53% (34.37) vs 16.67% (43.30), z = -2.353, p = 0.019] and day 7, [53.85% (28.90) vs 30.22% (38.61), z = -3.186, p = 0.001]. Lactate clearance over time was well observed in the intervention group, [X2 (2) = 29.356, p < 0.001] but not in the control group, [X2 (2) = 3.152, p = 0.207]. Significant mSOFA score reduction over time was also observed in the intervention group, [X2 (3) = 39.330, p < 0.001]. All-cause mortality within 7 days was not different, [X2 (1) = 0.949, p = 0.330, OR 0.949, 95% CI (0.51 – 7.12)].
Conclusion: Thiamine supplementation in sepsis patient was benefit in lactate clearance starting from day 3 and reduction of mSOFA score starting from day 7. But it did not show the mortality benefit within 7 days period.
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References
I. World Health Organization. Sepsis. 2020.
II. Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, et al. Global, regional, and national sepsis incidence and mortality, 1990–2017: analysis for the Global Burden of Disease Study. The Lancet. 2020 Jan 18;395(10219):200–11.
III. Ministry of Health and Sports. Hospital Statistics Report (2014-16). 2018.
IV. Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan 1;50(1):23–36.
V. Donnino MW, Andersen LW, Chase M, Berg KM, Tidswell M, Giberson T, et al. Randomized, Double-Blind, Placebo-Controlled Trial of Thiamine as a Metabolic Resuscitator in Septic Shock: A Pilot Study. Crit Care Med. 2016 Feb;44(2):360–7.
VI. Costa NA, Gut AL, de Souza Dorna M, Pimentel JAC, Cozzolino SMF, Azevedo PS, et al. Serum thiamine concentration and oxidative stress as predictors of mortality in patients with septic shock. J Crit Care. 2014;29(2):249–52.
VII. Attaluri P, Castillo A, Edriss H, Nugent K. Thiamine Deficiency: An Important Consideration in Critically Ill Patients. Am J Med Sci. 2018 Oct 1;356(4):382–90.
VIII. Heming N, Salah A, Meng P, Sivanandamoorthy S, Bounab R, Chevret S, et al. Thiamine status and lactate concentration in sepsis: A prospective observational study. Med U S. 2020;99(7).
IX. Nguyen HB, Rivers EP, Knoblich BP, Jacobsen G, Muzzin A, Ressler JA, et al. Early lactate clearance is associated with improved outcome in severe sepsis and septic shock. Crit Care Med. 2004;32(8):1637–42.
X. Woolum JA, Abner EL, Kelly A, Thompson Bastin ML, Morris PE, Flannery AH. Effect of Thiamine Administration on Lactate Clearance and Mortality in Patients With Septic Shock. Crit Care Med. 2018 Nov;46(11):1747–52.
XI. Harun NF, Cheah SK, Yusof A, Lau C, Masdar A, Mahdi SNM, et al. Intravenous thiamine as an adjuvant therapy for hyperlactatemia in septic shock patients. Crit Care Shock. 2019 Jan 1;22:288–98.
XII. Nasution AH, Yulianda RS. The Effect of Thiamine Administration on Interleukin-6 (Il-6) Enzyem, Lactate and Sequential Organ Failure Assessment (SOFA) Score in Patients with Sepsis. J Drug Alcohol Res [Internet]. 2020 Jul 14;9(2020). Available from:
XIII. Petsakul S, Morakul S, Tangsujaritvijit V, Kunawut P, Singhatas P, Sanguanwit P. Effects of thiamine on vasopressor requirements in patients with septic shock: a prospective randomized controlled trial. BMC Anesthesiol. 2020 Dec;20(1):280.
XIV. Miyamoto Y, Aso S, Iwagami M, Yasunaga H, Matsui H, Fushimi K, et al. Association Between IV Thiamine and Mortality in Patients With Septic Shock: A Nationwide Observational Study. Crit Care Med. 2020 Aug;48(8):1135–9.