Treatment with intravenous vitamin C, hydrocortisone, and thiamine does not improve the duration of time alive and vasopressor administration-free compared with intravenous hydrocortisone alone among patients with septic shock, according to a study published online Jan. 17 in the Journal of the American Medical Association.
Tomoko Fujii, M.D., Ph.D., from Monash University in Melbourne, Australia, and colleagues conducted a clinical trial in 10 intensive care units in Australia, New Zealand, and Brazil involving 216 patients fulfilling the Sepsis-3 definition of septic shock. Patients were randomly assigned to the intervention group, which included intravenous vitamin C, hydrocortisone, and thiamine (109 patients), or to the control group, which included intravenous hydrocortisone (107 patients) until shock resolution or up to 10 days; 211 patients provided consent and completed the primary outcome measurement.
The researchers found that time alive and vasopressor-free up to day 7 was 122.1 and 124.6 hours in the intervention and control groups, respectively; the median of all paired differences was −0.6 hours (95 percent confidence interval [CI], −8.3 to 7.2 hours; P = 0.83). Nine of 10 prespecified secondary outcomes showed no statistically significant difference. Ninety-day mortality was 28.6 percent in the intervention group and 24.5 percent in the control group (hazard ratio, 1.18; 95 percent CI, 0.69 to 2.00). There were no reports of serious adverse events.
"There appears to be no immediate justification for the adoption of high-dose vitamin C, alone or in combination, as a component of treatment for sepsis," writes the author of an accompanying editorial.