ATESS
Trial question
What is the effect of combination therapy of vitamin C and thiamine in patients with septic shock?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
60.0% female
40.0% male
N = 111
111 patients (67 female, 44 male)
Inclusion criteria: adult patients with septic shock
Key exclusion criteria: transfer from another hospital with vasopressor administration or mechanical ventilator support, an underlying terminal-stage disease, taking at least 1 g/day of vitamin C or receiving intravenous thiamine prior to enrollment, cardiac arrest prior to enrollment, renal or ureteral stones
Interventions
N=53 vitamin C and thiamine (intravenous vitamin C 50 mg/kg, maximum single dose 3 g and thiamine 200 mg administration every 12 h for a total of 48 h)
N=58 placebo (identical volume of 0.9% saline with the same protocol)
Primary outcome
Delta Sequential Organ Failure Assessment score
3
3
3.0
2.3
1.5
0.8
0.0
Vitamin C and thiamine
Placebo
No significant difference ↔
No significant difference in delta SOFA score (3 vs. 3 ; )
Secondary outcomes
No significant difference in death at 28 days (20.8% vs. 15.5%; AD 5.2%, 95% CI -9.1 to 19.6)
No significant difference in shock reversal (83% vs. 84.5%; ARD -1.5, 95% CI -15.2 to 12.3)
Borderline significant increase in vasopressor-free days (11 days vs. 11 days; )
Safety outcomes
No significant differences in ventilator-free days, new-onset AKI, ICU-free days, reduction of procalcitonin.
Significant difference in adverse events (0% vs. 3.5%).
Conclusion
In adult patients with septic shock, vitamin C and thiamine were not superior to placebo with respect to delta SOFA score.
Reference
Sung Yeon Hwang, Seung Mok Ryoo, Jong Eun Park et al. Combination therapy of vitamin C and thiamine for septic shock: a multi-centre, double-blinded randomized, controlled study. Intensive Care Med. 2020 Nov;46(11):2015-2025.
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