Combination of vitamin C, thiamine and hydrocortisone added to standard treatment in the management of sepsis: results from an open label randomised controlled clinical trial and a review of the literature.

Background: Combination of vitamin C, hydrocortisone and thiamine have recently been used in sepsis but data of efficacy are conflicting and no data are available from developing countries. We sought to study the effect of addition of this combination to standard care in patients with sepsis/septic shock in a north Indian setting.
Methods: In a prospective, open label, randomised fashion, 100 patients with sepsis/septic shock were recruited to receive either standard therapy alone (control group, n = 50) or a combination of vitamin C, thiamine and hydrocortisone (treatment group, n = 50) in addition. The patients were followed for various clinical and laboratory parameters, in-hospital and 30-day mortality, duration of vasopressor use, lactate clearance, duration of hospital stay, and change in serum lactate and the SOFA score over the first 4 days.
Results: The 2 groups were matched for basic characteristics. The in-hospital mortality (28% in controls and 24% in treatment group, p = .82) and 30-day mortality (42% in controls and 40% in treatment group, p = 1.00) was not significantly different in the 2 groups. However, there was a significant difference in duration of vasopressor use (96.13 ± 40.50 h in control group v/s 75.72 ± 30.29 h in treatment group, p value = .010) and lactate clearance (control group: 41.81% v/s treatment group: 56.83%, p value =.031) between 2 groups.Conclusions: Addition of vitamin C, hydrocortisone, and thiamine into standard care of sepsis does not improve in-hospital or 30 day mortality. However lower vasopressor use and faster lactate clearance is observed with treatment.

RCT Entities:   Population Interventions Outcomes