Clinical Efficacy of Megadose Vitamin C in Sepsis (CEMVIS)

May 8, 2026 updated by: Liu Zhanguo, Zhujiang Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

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 Yunfu People' s Hospital, Yunfu, Guangdong, China
  3. Department of Critical Care Medicine of Zhongshan People's Hospital, Zhongshan, Guangdong, China
  4. Department of Critical Care Medicine of Nanfang Hospital,Guangzhou, 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
234

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: zhanguo Liu, M.D.PhD
  • Phone Number: +862062782927
  • Email: zhguoliu@163.com

Study Locations

  • China
      • Guanzhou, China
        • Department of Critical Care Medicine of Nanfang Hospital of Southern Medical University
    • Guangdong
      • Guanzhou, Guangdong, China
        • Department of Critical Care Medicine of Zhujiang Hospital,Southern Medical University
      • Yunfu, Guangdong, China, 527300
        • Department of Critical Care Medicine of Yunfu People's Hospital
    • Guangzhou
      • Zhongshan, Guangzhou, China, 528403
        • Department of Critical Care Medicine of Zhongshan People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: 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 Comparator: Placebo group
5% glucose solution 48 ml every 12 h for 4 days or until ICU discharge.
Drug: 5% glucose injection
5% glucose solution 48 ml every 12 h for 4 days or at ICU discharge.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
28-day all-cause mortality
Time Frame: The outcome will be assessed at the 28 day after enrollment
All-cause mortality from the enrollment to the 28th days
The outcome will be assessed at the 28 day after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
liver function(1)
Time Frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
the serum level of Alanine transaminase(ALT)
The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
liver function(2)
Time Frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
the serum level of Aspartate transaminase (AST)
The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
liver function(3)
Time Frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
the serum level of total bilirubin
The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
lung function
Time Frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
oxygenation index(PaO2/FiO2),the patients treated with extracorporeal membrane oxygenation will not collect this indicator.
The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
kidney function(1)
Time Frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
serum level of Creatinine (Cr)
The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
kidney function(2)
Time Frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
serum level of blood urea nitrogen(BUN)
The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
kidney function(3)
Time Frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
serum level of Cystatin(Cys)
The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
inflammatory response(1)
Time Frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
the serum level of interleukin-6(IL-6)
The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
inflammatory response(2)
Time Frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
the serum level of C-reactive protein(CRP)
The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
Indicators of infection(1)
Time Frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
the serum level of procalcitonin(PCT)
The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
Indicators of infection(2)
Time Frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
the level of white blood cell count(WBC)
The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
The level of lactate
Time Frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
the serum level of lactic acid
The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
Sequential Organ Failure Assessment (SOFA) score
Time Frame: The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score. SOFA score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. The highest score for each of the six items is 4 points, and the lowest score is 0 points. Finally, the scores of the six items are summed to get the value of the sofa score. The range of the sofa score is 0-24.Higher values represent a worse outcome.
The outcome will be assessed at the 0, 1 ,2 ,4 day after enrollment
The cessation of mechanical ventilation(MV) administration
Time Frame: The outcome will be assessed at the 28 day after enrollment
The duration from the MV administration to the successful cessation in hours( The successful cessation is defined as the termination of MV for more than 48-hours. This outcome measure is intended only for patients receiving MV)
The outcome will be assessed at the 28 day after enrollment
The cessation of vasoactive drugs administration
Time Frame: The outcome will be assessed at the 28 day after enrollment
The duration from the vasoactive drugs administration to the successful cessation in hours( The successful cessation is defined as the attainment of a clinician-prescribed mean arterial pressure target for more than 24-hours without the use of vasoactive drugs.This outcome measure is intended only for patients receiving vasoactive drugs)
The outcome will be assessed at the 28 day after enrollment
The duration of CRRT
Time Frame: The outcome will be assessed at the 28 day after enrollment
The duration of CRRT therapy in hours( This outcome measure is intended only for patients receiving CRRT)
The outcome will be assessed at the 28 day after enrollment
ICU length of stay
Time Frame: The outcome will be assessed at the 28 day after enrollment
ICU length of stay
The outcome will be assessed at the 28 day after enrollment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: The outcome will be assessed at the 28 day after enrollment
A adverse event refers to any adverse medical event that occur after the intervention of trial. The adverse events are not necessarily causally related to the trial treatment.
The outcome will be assessed at the 28 day after enrollment
Incidence of serious adverse events
Time Frame: The outcome will be assessed at the 28 day after enrollment
Any adverse medical event occurs at any dose that meets one or more of the following criteria: 1. causes death 2.life-threatening 3. requires hospitalization or hospitalization for an extended period of time 4. causes permanent or significant disability and functional defects 5. causes deformity.
The outcome will be assessed at the 28 day after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhujiang Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhanguo Liu, M.D.PhD, Department of Critical Care Medicine of Zhujiang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-KY-069-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The datasets generated and analyzed during the study are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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