CITRIS-ALI
Trial question
What is the effect of vitamin C infusion in patients with sepsis and severe acute respiratory failure?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 167
167 patients (77 female, 90 male).
Inclusion criteria: patients with sepsis and ARDS present for < 24 hours.
Key exclusion criteria: known allergy to vitamin C; > 48 hours elapsed since ARDS; moribund and not expected to survive 24 hours; ILD, diffuse alveolar hemorrhage, diabetic ketoacidosis, or an active kidney stone.
Interventions
N=84 vitamin C (intravenous infusion of 50 mg/kg of body weight in dextrose 5% in water every 6 hours for 96 hours).
N=83 placebo (intravenous infusion of dextrose 5% in water only every 6 hours for 96 hours).
Primary outcome
Change in modified Sequential Organ Failure Assessment scores from enrollment to 96 hours
3 points
3.5 points
3.5 points
2.6 points
1.8 points
0.9 points
0.0 points
Vitamin
C
Placebo
No significant
difference ↔
No significant difference in change in modified SOFA scores from enrollment to 96 hours (3 points vs. 3.5 points; AD -0.1 points, 95% CI -1.23 to 1.03).
Secondary outcomes
No significant difference in CRP levels at 168 hours (54.1 mcg/mL vs. 46.1 mcg/mL; AD 7.94 mcg/mL, 95% CI -8.23 to 24.1).
No significant difference in thrombomodulin levels at 168 hours (14.5 ng/mL vs. 13.8 ng/mL; AD 0.69 ng/mL, 95% CI -2.8 to 4.2).
Significant increase in death at day 28 (29.8% vs. 46.3%; ARD 16.58, 95% CI 2 to 31.1).
Safety outcomes
No significant difference in ventilator-free days.
Significant differences in hospital-free days (22.6 days vs. 15.5 days), ICU-free days (10.7 days vs. 7.7 days), transfer out of ICU by hour ≤ 168 (25% vs. 12.5%).
Conclusion
In patients with sepsis and ARDS present for < 24 hours, vitamin C was not superior to placebo with respect to change in modified SOFA scores from enrollment to 96 hours.
Reference
Alpha A Fowler rd, Jonathon D Truwit, R Duncan Hite et al. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial. JAMA. 2019 Oct 1;322(13):1261-1270.
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