Using high doses of Vitamin C to treat sepsis

Clinical Efficacy of Megadose Vitamin C in Sepsis (CEMVIS): A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Trial

This study is testing whether high doses of Vitamin C can help people with sepsis or septic shock recover better and survive longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 234 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zhujiang Hospital (Academic / other)
• Locations: 4 sites (Guanzhou, Guangdong and 3 other locations)
• Trial ID: NCT05194189 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of megadose Vitamin C in patients diagnosed with sepsis or septic shock. In a multicenter, randomized, single-blind, placebo-controlled design, participants will receive either Vitamin C injections or a placebo for four days or until ICU discharge. The primary goal is to assess the impact on 28-day all-cause mortality, alongside evaluating organ function and inflammatory response. The study aims to provide insights into the safety and potential benefits of Vitamin C as an adjunctive treatment for sepsis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a confirmed diagnosis of sepsis and elevated procalcitonin levels.

Not a fit: Patients under 18 or over 80, those with certain comorbidities, or those not committed to aggressive life support may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce mortality rates in patients suffering from sepsis.

How similar studies have performed: While the use of Vitamin C in sepsis is a novel approach, preliminary studies have shown promising results, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Guanzhou, Guangdong and 3 other locations

• Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University — Guanzhou, Guangdong, China (Recruiting)
• Department of Critical Care Medicine of Yunfu People's Hospital — Yunfu, Guangdong, China (Recruiting)
• Department of Critical Care Medicine of Zhongshan People's Hospital — Zhongshan, Guangzhou, China (Recruiting)
• Department of Critical Care Medicine of Nanfang Hospital of Southern Medical University — Guanzhou, China (Recruiting)

Study contacts

• Principal investigator: Zhanguo Liu, M.D.PhD — Department of Critical Care Medicine of Zhujiang Hospital
• Study coordinator: Zhanguo Liu, M.D.PhD

Conditions Sepsis; Septic Shock; megadose vitamin C