Clinical trial

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

NCT05194189

Name

2020-KY-069-05

Description

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.

Trial arms

Trial start

2022-02-08

Estimated PCD

2024-12-04

Trial end

2024-12-04

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

Megadose vitamin C group

5% glucose injection

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

Arms:

Placebo group

Size

234

Primary endpoint

28-day all-cause mortality

The outcome will be assessed at the 28 day after enrollment

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants in treatment group receive intravenous megadose vitamin C. The participants in control group receive 5% glucose injection with same volume.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 234, 'type': 'ESTIMATED'}}

Updated at

2024-03-19

1 organization

2 products

2 indications

Organization

Product

Indication

Indication

Product