VITAMINS Trial Summary
The VITAMINS trial aimed to determine whether the combination of vitamin C, hydrocortisone, and thiamine is more effective than hydrocortisone alone in expediting the resolution of septic shock. The trial included 216 patients with septic shock and compared the duration of time alive and free of vasopressor administration over 7 days between the two treatment groups.
Patients were randomly assigned to either the intervention group (n=109) receiving intravenous vitamin C (1.5 g every 6 hours), hydrocortisone (50 mg every 6 hours), and thiamine (200 mg every 12 hours), or the control group (n=107) receiving intravenous hydrocortisone alone until shock resolution or up to 10 days.
The primary outcome measured was the duration of time alive and free of vasopressor administration up to day 7. Secondary outcomes, including 90-day mortality, were also assessed. Among the randomized patients who completed the primary outcome measurement, no statistically significant difference was observed in the duration of time alive and vasopressor free up to day 7 between the two groups. The median difference was -0.6 hours (95% CI, -8.3 to 7.2 hours; P=0.83). Additionally, most of the prespecified secondary outcomes did not show a statistically significant difference.
Ninety-day mortality rates were similar between the intervention group (28.6%) and the control group (24.5%), with no significant difference observed (hazard ratio, 1.18; 95% CI, 0.69-2.00). No serious adverse events were reported during the trial.
In conclusion, the VITAMINS trial found that treatment with intravenous vitamin C, hydrocortisone, and thiamine did not result in a more rapid resolution of septic shock compared to treatment with intravenous hydrocortisone alone. The combination therapy did not significantly improve the duration of time alive and free of vasopressor administration over 7 days. These findings suggest that the addition of vitamin C and thiamine to hydrocortisone does not provide substantial benefits in the management of septic shock compared to hydrocortisone alone.