No role of vitamin C, hydrocortisone, thiamine cocktail for septic shock: JAMA
Delhi: Treatment with intravenous vitamin C, hydrocortisone, and thiamine does not lead to a more rapid resolution of septic shock compared with intravenous hydrocortisone alone, a recent study in the journal JAMA has suggested.
According to the study conducted on about 200 patients with septic shock, vitamin C cocktail compared with hydrocortisone alone didn't significantly improve the amount of time patients were alive and free of medicines that raise blood pressure (vasopressors) over seven days.
Sepsis is a body's overreaction to a severe infection, leading to multiple organ failure and, frequently, death. It affects an estimated 15–19 million cases per year worldwide. Over the years, there has been indications that vitamin C might be effective against sepsis. For instance, people with sepsis tend to have surprisingly low levels of vitamin C in their blood. A previous randomized trial of 24 patients showed that high-dose IV vitamin C attenuated organ failure associated with sepsis in a dose-dependent manner. However, it is unclear whether vitamin C, hydrocortisone, and thiamine are more effective than hydrocortisone alone in expediting the resolution of septic shock.
Tomoko Fujii, Monash University, Melbourne, Victoria, Australia, and colleagues determined whether the combination of vitamin C, hydrocortisone, and thiamine, compared with hydrocortisone alone, improves the duration of time alive and free of vasopressor administration in patients with septic shock.
The study (the VITAMINS trial) was set up by the ANZIC-RC across ten intensive care units in Australia, New Zealand and Brazil, looking at 216 patients in septic shock between May, 2018 and July, 2019. 216 patients were randomized to either the intervention group (n = 109), consisting of intravenous vitamin C (1.5 g every 6 hours), hydrocortisone (50 mg every 6 hours), and thiamine (200 mg every 12 hours), or to the control group (n = 107), consisting of intravenous hydrocortisone (50 mg every 6 hours) alone until shock resolution or up to 10 days.
The primary trial outcome was the duration of time alive and free of vasopressor administration up to day 7. Ten secondary outcomes were prespecified, including 90-day mortality.
Key findings of the study include:
- Among 216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63%]).
- Time alive and vasopressor free up to day 7 was 122.1 hours in the intervention group and 124.6 hours in the control group; the median of all paired differences was –0.6 hours.
- Of 10 prespecified secondary outcomes, 9 showed no statistically significant difference. Ninety-day mortality was 30/105 (28.6%) in the intervention group and 25/102 (24.5%) in the control group (hazard ratio, 1.18).
- No serious adverse events were reported.
"The findings of the VITAMINS trials are clear: in patients with septic shock from Australia, New Zealand and Brazil there was no signal of benefit with the high dose vitamin C, thiamine and hydrocortisone cocktail. The search for treatments that might improve the outcome of these very sick patients must now focus on other interventions," concluded the authors.
The study, "Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support Among Patients With Septic Shock" The VITAMINS Randomized Clinical Trial," is published in the Journal of the American Medical Association.