Status:
RECRUITING
Clinical Efficacy of Megadose Vitamin C in Sepsis
Lead Sponsor:
Zhujiang Hospital
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 fi...
Detailed Description
Investigational drug: Vitamin C for injection Study title: Clinical efficacy of megadose vitamin C in sepsis (CEMVIS): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial Prin...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Age\<18 years, or age\>80 years.
- Pregnancy or lactating
- A solid-organ or bone marrow transplant patients.
- Patients with myocardial infarction within the past 3 months.
- Advanced pulmonary fibrosis .
- Patients with cardiopulmonary resuscitation before enrollment.
- HIV-positive patients.
- granulocyte-deficient patients.
- blood/lymphatic system tumors are not remission.
- patients with limited care (lack of commitment to full aggressive life support).
- patients with long-term use of immunosuppressive drugs or with immunodeficiency.
- patients with advanced tumors.
- patients combined with non-infectious factors leading to the death(uncontrollable major bleeding, brain hernia, etc.).
- surgically unresolved infection sources(such as some intraperitoneal infection etc.)
- patients allergic to vitamin c.
- patients with G6PD deficiency.
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 4 2024
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT05194189
Start Date
February 8 2022
End Date
December 4 2024
Last Update
March 19 2024
Active Locations (4)
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1
Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Guanzhou, Guangdong, China
2
Department of Critical Care Medicine of Yunfu People's Hospital
Yunfu, Guangdong, China, 527300
3
Department of Critical Care Medicine of Zhongshan People's Hospital
Zhongshan, Guangzhou, China, 528403
4
Department of Critical Care Medicine of Nanfang Hospital of Southern Medical University
Guanzhou, China