LOVIT
Trial question
What is the role of intravenous vitamin C in adult patients with sepsis in the ICU?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 862
862 patients (324 female, 538 male).
Inclusion criteria: adult patients with sepsis receiving vasopressor therapy in the ICU.
Key exclusion criteria: contraindication to vitamin C therapy; receipt of open-label vitamin C; expected death or withdrawal of life-sustaining therapy within 48 hours.
Interventions
N=429 vitamin C (at a dose of 50 mg/kg of body weight every 6 hours for up to 96 hours).
N=433 placebo (dextrose 5% in water or normal saline every 6 hours for up to 96 hours).
Primary outcome
Composite of death or persistent organ dysfunction at day 28
44.5%
38.5%
44.5 %
33.4 %
22.3 %
11.1 %
0.0 %
Vitamin
C
Placebo
Significant
increase ▲
NNH = 16
Significant increase in death or persistent organ dysfunction at day 28 (44.5% vs. 38.5%; RR 1.21, 95% CI 1.04 to 1.4).
Secondary outcomes
No significant difference in death at day 28 (35.4% vs. 31.6%; RR 1.17, 95% CI 0.98 to 1.4).
No significant difference in median days without organ dysfunction at day 28 (17 days vs. 19.5 days; MD -2.43, 95% CI -7.23 to 2.37).
No significant difference in SOFA score at day 28 (6.5 points vs. 7.9 points; AD -1.42 points, 95% CI -3.98 to 1.14).
Safety outcomes
No significant differences in stage 3 AKI, hypoglycemia.
Conclusion
In adult patients with sepsis receiving vasopressor therapy in the ICU, vitamin C was inferior to placebo with respect to the composite of death or persistent organ dysfunction at day 28.
Reference
François Lamontagne, Marie-Hélène Masse, Julie Menard et al. Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit. N Engl J Med. 2022 Jun 23;386(25):2387-2398.
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