Evaluation of the Effects of a Combination of Vitamin C, Thiamine and Hydrocortisone vs Hydrocortisone Alone on ICU Outcome in Patients with Septic Shock: A Randomized Controlled Trial

Aims and background: Glucocorticoids, vitamin C and thiamine have important biological effects in patients with sepsis and septic shock. Multiple studies have demonstrated the beneficial role of a combination therapy of vitamin C, hydrocortisone and thiamine in patients with sepsis and septic shock in terms of mortality reduction, and increase in the number of days free of ventilators and vasopressors. Materials and methods: Patients who had septic shock were assessed for eligibility after intensive care unit (ICU) admission. After randomization, the treatment group received a combination of vitamin C, thiamine and hydrocortisone for a duration of 96 hours (16 doses) and the control group received hydrocortisone for a duration till the patient was on vasopressors. The primary outcome assessed was ICU mortality, and the key secondary outcome was the duration free of vasopressor administration at the end of 7 days. Results: A total of 86 patients were included in the study. Seventy percent of patients in the control group and 58 percent in the intervention group died during ICU stay. None of the primary and secondary outcomes were statistically significant. Conclusion: The use of a combination of vitamin C, hydrocortisone and thiamine has no added benefits over the use of hydrocortisone alone in patients with septic shock. Clinical significance: The results of this clinical trial shows that the use of a combination of vitamin C, hydrocortisone and thiamine in patients with septic shock is not useful and should not be a routine practice in critically ill septic patients.