Clinical Efficacy of Megadose Vitamin C in Sepsis (NCT05194189) | Clinical Trial Compass
CompletedPhase 2
Clinical Efficacy of Megadose Vitamin C in Sepsis
China234 participantsStarted 2022-02-08
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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.
What they're measuring
1
28-day all-cause mortality
Timeframe: The outcome will be assessed at the 28 day after enrollment