C-EASIE
Trial question
What is the role of early vitamin C administration in patients with sepsis or septic shock?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 292
292 patients (103 female, 189 male).
Inclusion criteria: adult patients admitted to emergency department with sepsis or septic shock.
Key exclusion criteria: contraindications to vitamin C therapy; DNI or comfort-measures-only status; antibiotic administration as a single dose or as a prophylactic treatment; weight < 45 kg; pregnancy or breastfeeding; chronic iron overload.
Interventions
N=147 vitamin C (1.5 g intravenous infusion mixed with 50 mL solution of normal saline every 6 hours for 4 days).
N=145 placebo (normal saline infusion every 6 hours for 4 days).
Primary outcome
Average post-baseline patient Sequential Organ Failure Assessment score on day 2-5
1.98 points
2.19 points
2.2 points
1.6 points
1.1 points
0.5 points
0.0 points
Vitamin
C
Placebo
No significant
difference ↔
No significant difference in average post-baseline patient SOFA score on day 2-5 (1.98 points vs. 2.19 points; RR 0.91, 95% CI 0.77 to 1.08).
Secondary outcomes
No significant difference in death at day 28 (12% vs. 7.9%; AD 4%, 95% CI -3 to 11).
No significant difference in mean maximum SOFA score (5.45 points vs. 5.93 points; MD -0.48, 95% CI -1.69 to 0.74).
No significant difference in median length of hospital stay (10 days vs. 11 days; HR 0.97, 95% CI 0.77 to 1.23).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients admitted to emergency department with sepsis or septic shock, vitamin C was not superior to placebo with respect to average post-baseline patient SOFA score on day 2-5.
Reference
Stefanie Vandervelden, Bente Cortens, Steffen Fieuws et al. Early administration of vitamin C in patients with sepsis or septic shock in emergency departments: a multicenter, double-blind, randomized controlled trial: the C-EASIE trial. Crit Care. 2025 Apr 23;29(1):160.
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