6/28/23, 12:10 AM CITRIS-ALI Pathway Feedback Search Clinical Topics Home Studies CITRIS ALI CITRIS ALI Disease Disease Acute respiratory distress syndr Sepsis and septic shock 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 N = 167 54.0% male 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 3.5 points 3.5 https://web.pathway.md/studies/rec5OXjXCoxndqGZ9 1/2 6/28/23, 12:10 AM CITRIS-ALI Pathway 3 2.6 points 1.8 points 0.9 points No significant difference 0.0 points Vitamin C Placebo No significant difference in change in modified Sequential Organ Failure Assessment 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 g/mL vs. 46.1 g/mL; AD 7.94 g/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 Sequential Organ Failure Assessment 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. Open reference URL https://web.pathway.md/studies/rec5OXjXCoxndqGZ9 2/2