Clinical Efficacy of Megadose Vitamin C in Sepsis (CEMVIS): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
Who is this study for? Patients with Sepsis, Septic Shock
What treatments are being studied? Vitamin C
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
In this multicenter, randomized, single-blind, placebo-controlled clinical trial. Patients will be randomly assigned to receive Vitamin C or placebo for 4 days or until ICU discharge (whatever come first). The primary outcome is 28-day all-cause mortality.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Meets the diagnostic criteria for sepsis-3 developed by the American Society of Critical Care Medicine (SCCM)/European Critical Care Medicine Association (ESICM)
• Age ≥18 years old and age ≤80 years old.
• Procalcitonin ≥2 ng/ml
Locations
Other Locations
China
Department of Critical Care Medicine of Nanfang Hospital of Southern Medical University
RECRUITING
Guanzhou
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
RECRUITING
Guanzhou
Department of Critical Care Medicine of Yunfu People's Hospital
RECRUITING
Yunfu
Department of Critical Care Medicine of Zhongshan People's Hospital
RECRUITING
Zhongshan
Contact Information
Primary
Zhanguo Liu, M.D.PhD
zhguoliu@163.com
+862062782927
Time Frame
Start Date: 2022-02-08
Estimated Completion Date: 2024-12-04
Participants
Target number of participants: 234
Treatments
Experimental: Megadose vitamin C group
12 g vitamin C (48 ml) will intravenously injected by a infusion pump every 12 h for 4 days or until ICU discharge
Placebo_comparator: Placebo group
5% glucose solution 48 ml every 12 h for 4 days or until ICU discharge.
Related Therapeutic Areas
Sponsors
Leads: Zhujiang Hospital