Use of Vitamin C, Thiamine, and Hydrocortisone for Sepsis fails in major study

USA: Treatment with vitamin C, thiamine, and hydrocortisone does not significantly improve ventilator- and vasopressor-free days compared to placebo in critically ill patients, finds a recent study in the journal JAMA. However, a clinically important difference could not have been detected as the trial was terminated early for administrative reasons and may have been underpowered.

Sepsis, body's extreme response to an infection, is a common life-threatening emergency with substantial morbidity and mortality. A combination of thiamine, vitamin C, and corticosteroids has been proposed as a potential treatment for sepsis patients. Jonathan E. Sevransky, Emory University School of Medicine, Atlanta, Georgia, and colleagues aimed to determine whether a combo of these three every 6 hours increases ventilator- and vasopressor-free days compared with placebo in patients with sepsis.

For the purpose, the researchers performed a multicenter, randomized, double-blind, adaptive-sample-size, placebo-controlled trial. The trial was conducted in adult patients with sepsis-induced respiratory and/or cardiovascular dysfunction. 

The study included participants enrolled in the emergency departments or intensive care units at 43 hospitals in the US between August 2018 and July 2019. After enrollment of 501 participants, funding was withheld, leading to an administrative termination of the trial. All study-related follow-up was completed by January 2020.