Is Thiamine Administration Effective in Sepsis or Not? A Randomized Controlled Trial
Authors/Creators
- 1. Consultant Physician, No. (1) Defence Services General Hospital (1000-Bedded), Yangon.
- 2. Consultant Physician & Nephrologist, No. (1) Defence Services General Hospital (1000-Bedded), Yangon.
- 3. Professor & Head of department, Department of Medicine and Department of Nephrology, Defence Services Medical Academy, Yangon.,Senior Consultant Physician & Nephrologist, Department of Medicine and Department of Nephrology, No.(1) Defence Services General Hospital (1000-Bedded), Yangon.
Description
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.