Study Results
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Basic Information
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RECRUITING
PHASE2
234 participants
INTERVENTIONAL
2022-02-08
2024-12-04
Brief Summary
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Detailed Description
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Study title: Clinical efficacy of megadose vitamin C in sepsis (CEMVIS): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
Principal Investigator: Zhanguo Liu, professor, Department of Critical Care Medicine, Zhujiang Hospital, Southern Medical University
Study subjects: Adult septic/septic shock patients with procalcitonin(PCT)≥2ng/ml at recruitment.
Study phase: Investigator Initiated Trial(IIT)
Study objectives: The objective of the study is to determine whether megadose vitamin c, compared to placebo, improve the prognosis of sepsis, including the reduction in mortality, the protection of organ function and reduction of inflammatory response, and to determine the safety of megadose vitamin c in patients with sepsis.
Study design: A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial
Method： Megadose vitamin C group: routine treatment follow the recommendation of the guidelines for sepsis in 2021+ 12 g vitamin C (48 ml) injection every 12 h for 4 days or until ICU discharge (death or transfer from ICU to general ward or discharge), whatever come first. Placebo control group: routine treatment follow the recommendation of the guidelines for sepsis in 2021 + 48ml 5% glucose injection every 12 h for 4 days or until ICU discharge (death or transfer from ICU to general ward or discharge), whatever come first.
Course: 4 days
Sample size: 234
The number of study center: 4
Study center:
1. Department of Critical Care Medicine of Zhujiang Hospital,Guangzhou, Guangdong, China
2. Department of Critical Care Medicine of The First People's Hospital of Foshan, Foshan, Guangdong, China
3. Department of Critical Care Medicine of Dongguan People's Hospital, Dongguan, Guangdong,China
4. Department of Critical Care Medicine of Yunfu People' s Hospital, Yunfu, Guangdong, China
5. Department of Critical Care Medicine of Zhongshan People's Hospital, Zhongshan, Guangdong, China
Primary endpoint: 28-day all-cause mortality.
Secondary endpoints:
1. The state of liver function: the serum level of transaminase(AST、ALT)、total bilirubin at 96 h after randomization
2. The state of lung function: oxygenation index(PaO2/FiO2) at 96h after randomization
3. The state of kidney function: serum level of Creatinine (Cr)、blood urea nitrogen(BUN)、Cystatin(Cys) at 96 h after randomization
4. The state of inflammatory response: the serum level of interleukin-6(IL-6) and C-reactive protein(CRP) at 96 h after randomization.
5. The state of infection: the serum level of procalcitonin(PCT) and white blood cell （WBC） at 96 h after randomization.
6. The state of circulation system: the serum level of lactate at 96 h after randomization
7. Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score at 96 h after randomization
8. The duration of successful cessation of supportive therapies for organ dysfunction including vasoactive agents, mechanical ventilation.
9. The duration of continuous renal replacement therapy(CRRT)
10. The length of stay in ICU
Safety endpoints：
1. adverse events
2. Serious adverse events
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Vitamin C
12 g vitamin C (48 ml) will be intravenously injected by a infusion pump every 12 h for 4 days or at ICU discharge
Placebo group
5% glucose solution 48 ml every 12 h for 4 days or until ICU discharge.
5% glucose injection
5% glucose solution 48 ml every 12 h for 4 days or at ICU discharge.
Interventions
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Vitamin C
12 g vitamin C (48 ml) will be intravenously injected by a infusion pump every 12 h for 4 days or at ICU discharge
5% glucose injection
5% glucose solution 48 ml every 12 h for 4 days or at ICU discharge.
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years old and age ≤80 years old.
* Procalcitonin ≥2 ng/ml
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Zhujiang Hospital
OTHER
Responsible Party
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Liu Zhanguo
Vice director of the department of critical care medicine, Principal Investigator
Principal Investigators
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Zhanguo Liu, M.D.PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Critical Care Medicine of Zhujiang Hospital
Locations
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Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
Guanzhou, Guangdong, China
Department of Critical Care Medicine of Yunfu People's Hospital
Yunfu, Guangdong, China
Department of Critical Care Medicine of Zhongshan People's Hospital
Zhongshan, Guangzhou, China
Department of Critical Care Medicine of Nanfang Hospital of Southern Medical University
Guanzhou, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Liu F, Zhu Y, Zhang J, Li Y, Peng Z. Intravenous high-dose vitamin C for the treatment of severe COVID-19: study protocol for a multicentre randomised controlled trial. BMJ Open. 2020 Jul 8;10(7):e039519. doi: 10.1136/bmjopen-2020-039519.
Chang P, Liao Y, Guan J, Guo Y, Zhao M, Hu J, Zhou J, Wang H, Cen Z, Tang Y, Liu Z. Combined Treatment With Hydrocortisone, Vitamin C, and Thiamine for Sepsis and Septic Shock: A Randomized Controlled Trial. Chest. 2020 Jul;158(1):174-182. doi: 10.1016/j.chest.2020.02.065. Epub 2020 Mar 31.
Other Identifiers
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2020-KY-069-05
Identifier Type: -
Identifier Source: org_study_id
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