Clinical Efficacy of Megadose Vitamin C in Sepsis

NCT05194189 | Completed Phase 2 DMC

• 1 other identifier: 2020-KY-069-05
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 4

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 first). The primary outcome is 28-day all-cause mortality.

Conditions

Sepsis; Septic Shock

Keywords

megadose vitamin C

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality

  All-cause mortality from the enrollment to the 28th days

  The outcome will be assessed at the 28 day after enrollment

Secondary Outcomes (17)

• liver function(1)

  The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment

• liver function(2)

  The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment

• liver function(3)

  The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment

• lung function

  The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment

• kidney function(1)

  The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment

Other Outcomes (2)

• Incidence of adverse events

  The outcome will be assessed at the 28 day after enrollment

• Incidence of serious adverse events

  The outcome will be assessed at the 28 day after enrollment

Study Arms (2)

Megadose vitamin C group

EXPERIMENTAL

12 g vitamin C (48 ml) will intravenously injected by a infusion pump every 12 h for 4 days or until ICU discharge

Drug: Vitamin C

Placebo group

PLACEBO COMPARATOR

5% glucose solution 48 ml every 12 h for 4 days or until ICU discharge.

Drug: 5% glucose injection

Interventions

Vitamin C DRUG

12 g vitamin C (48 ml) will be intravenously injected by a infusion pump every 12 h for 4 days or at ICU discharge

Megadose vitamin C group

5% glucose injection DRUG

5% glucose solution 48 ml every 12 h for 4 days or at ICU discharge.

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (4)

Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University

Guanzhou, Guangdong, China

Location

Department of Critical Care Medicine of Yunfu People's Hospital

Yunfu, Guangdong, 527300, China

Location

Department of Critical Care Medicine of Zhongshan People's Hospital

Zhongshan, Guangzhou, 528403, China

Location

Department of Critical Care Medicine of Nanfang Hospital of Southern Medical University

Guanzhou, China

Location

Related Publications (3)

• Wang, G., Liang, Z., Guan, J. et al. Clinical Efficacy of Megadose Vitamin C in Sepsis: Protocol for a Multicenter Randomized Single-Blind Placebo-Controlled Clinical Trial. Intensive Care Res 4, 129-136 (2024). https://doi.org/10.1007/s44231-024-00066-7

  BACKGROUND

• 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.

  PMID: 32641343 BACKGROUND

• 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.

  PMID: 32243943 BACKGROUND

Related Links

• study protocol

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Ascorbic Acid; Glucose

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Hexoses; Monosaccharides; Sugars

Study Officials

• Zhanguo Liu, M.D.PhD

  Department of Critical Care Medicine of Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of the department of critical care medicine, Principal Investigator

Model Details: The participants in treatment group receive intravenous megadose vitamin C. The participants in control group receive 5% glucose injection with same volume.

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 18, 2022
• Study Start: February 8, 2022
• Primary Completion: December 4, 2024
• Study Completion: December 25, 2024
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

CN (4)