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Adding vitamin C, thiamine to hydrocortisone fails to improve sepsis outcomes
When compared with hydrocortisone alone, treatment with a combination of IV vitamin C, thiamine and hydrocortisone did not prolong time alive and free of vasopressor administration for patients with septic shock, according to data from the VITAMINS trial.
The multicenter, open-label, parallel-group randomized trial was conducted at 10 ICUs in Australia, New Zealand and Brazil. The researchers randomly assigned adults with septic shock, as defined by criteria from the Sepsis-3 consensus, to IV vitamin C 1.5 g every 6 hours, hydrocortisone 50 mg every 6 hours and thiamine 200 mg every 12 hours or IV hydrocortisone 50 mg alone every 6 hours until shock resolution or up to 10 days.
A total of 211 patients (mean age, 61 years; 63% men) were included in the primary analysis.
In terms of the primary outcome, results revealed no difference in median time alive and free of vasopressor administration between the intervention and control groups (122.1 hours vs. 124.6 hours; median of all paired differences between groups, –0.6 hours; P = .83).
The researchers also found no significant differences between the intervention and control groups in 10 prespecified secondary outcomes, including all-cause mortality at 90 days (28.6% vs. 24.5%; HR = 1.18; 95% CI, 0.69-2).
Two patients in the intervention group and one patient in the control group experienced adverse events, but no serious adverse events or suspected unexpected serious adverse reactions occurred.
“The finding suggests that treatment with IV vitamin C, hydrocortisone and thiamine does not lead to a more rapid resolution of septic shock compared with IV hydrocortisone alone,” the researchers wrote.
In an accompanying editorial, Andre C. Kalil, MD, MPH, from the department of internal medicine at the University of Nebraska Medical Center, noted that six of eight randomized clinical trials evaluating vitamin C as a treatment for sepsis and septic shock did not show a mortality benefit, nor did five of six observational studies. Notably, those studies that did suggest an effect of vitamin C on mortality had important limitations, he added.
Nevertheless, this remains a popular area of study, with 37 trials in several countries currently examining vitamin C, alone or combined with other agents, for sepsis, according to Kalil.
“The results of the clinical trial by Fujii et al in this issue of JAMA, added to the cumulative evidence from 13 different studies performed in 10 different countries, indicate that high-dose vitamin C with or without thiamine and steroids does not provide significant survival benefits for patients with sepsis or septic shock,” he wrote. “Given that other studies are forthcoming, there appears to be no immediate justification for adoption of high-dose vitamin C, alone or in combination, as a component of treatment for sepsis.” – by Melissa Foster
Disclosures: Fujii reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures. Kalil reports no relevant financial disclosures.