In the United States, at least 1.7 million adults suffer from sepsis each year and about 270,000 die as a result. The current standard-of-care for sepsis includes early appropriate antibiotics, aggressive fluid resuscitation, and blood pressure support with vasopressors to prevent septic shock, which can lead to respiratory and organ failure and death. Because of the deleterious consequences of the condition and a lack of tried-and-true therapies to decrease mortality, investigators are examining treatments that a have good track record with sepsis and further studying their effects.
“Despite many years of clinical trials and elucidation of sepsis pathophysiology, there are no proven ancillary therapies to decrease sepsis mortality and no gold standard test for its diagnosis,” Katherine Nugent, MD, an emergency medicine physician at Emory University Hospital and an investigator on the trial, told Contagion
® in a recent interview.
Previous research has demonstrated success in treating sepsis using intravenous vitamin C, thiamine, and hydrocortisone. Inspired by this success, Dr. Nugent and her colleagues from Emory launched The VItamin C, Thiamine And Steroids in Sepsis (VICTAS) clinical trial
in August 2018 to investigate the use of the combination therapy to reduce the duration of cardiovascular and respiratory organ dysfunction and to reduce 30-day mortality in critically ill patients with sepsis.
“If this study shows promising results for the combination therapy of vitamin C, thiamine, and corticosteroids in sepsis, it has the potential to impact millions of lives both in the United States and worldwide,” Dr. Nugent said. “Such a combination carries fewer risks and is more widely available than previously studied ancillary therapies, increasing its possible influence over this widespread, deadly, and costly public health crisis.”
The double-blind, placebo-controlled, adaptive randomized clinical trial will enroll as many as 2000 patients with sepsis to receive either the combination therapy or a placebo along with standard intensive medical treatment for sepsis, which includes high doses of antibiotics. The primary outcome for the study is vasopressor and ventilator-free days at 30 days (+/-3 days) after randomization, which will be determined by recording all start and stop days of these measures, according to the trial description.
The study will continue to enroll participants aged 18 years and older who meet the inclusion and exclusion criteria, with an estimated primary completion date of December 2019 and a projected study completion date of October 2021. As of December 18, 2018, 75 are enrolled participants among 15 actively enrolling sites throughout the United States.
Worldwide, more than 30 million people each year develop sepsis, including 3 million infants and 1.2 million children—leading to an estimated 6 million deaths, according to the World Health Organization
. About 1 in 3 patients
who die in US hospitals each year have sepsis, making it the third-leading cause of death for Americans.
The infection is also costly for patients in the United States, exceeding $20 billion annually. According to Dr. Nugent, if the new combination therapy trial is successful, the treatment has the potential to decrease risks and costs associated with sepsis.
The new trial is funded by The Marcus Foundation based in Atlanta, Georgia.
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