Emory Physicians Collaborate on Clinical Trial Testing Vitamin and Steroid Combination in Sepsis Patients
A new randomized, placebo-controlled, double-blind clinical trial at Emory University and 45 other sites around the U.S. is testing a combination of vitamins and steroids in patients diagnosed with sepsis, a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is the third leading cause of death in the U.S., and causes annual hospitalization expenditures exceeding $20 billion.
Jon Sevransky, MD, MHS, of the Emory Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, is the principal investigator of the VICTAS Study (Vitamin C, Thiamine And Steroids in Sepsis), David Wright, MD, interim chair of the Emory Department of Emergency Medicine, is co-PI, and emergency medicine physician Katherine Nugent, MD, is the local site PI at Emory. Additional Emory participants include Craig Coopersmith, MD, vice chair of research for the Emory Department of Surgery and interim director of the Emory Critical Care Center, and Timothy Buchman, PhD, MD, medical director of Emory's Electronic ICU Service, both of whom serve on the trial's executive committee and are actively enrolling patients.
In 2017, positive results were published from a small study at an academic medical center in Virginia comparing the same combination therapy as in the VICTAS trial to similar control patients who did not receive combination therapy, but further study in a rigorous, randomized control trial setting was recommended. The three drugs have been used before to treat sepsis, but not regularly in combination. After becoming aware of this potentially revolutionary treatment, the Marcus Foundation in Atlanta, a major donor to Emory, approached Emory's critical care doctors and offered to fund a scientific study to determine if it actually worked.
"There have been more than 100 phase III clinical trials of pharmacological agents with the potential to improve sepsis outcomes, but few have worked, with only timely antibiotics demonstrating benefits for patients," says Dr. Sevransky. "We really want and need to find a better treatment for sepsis."
The phase III VICTAS trial has been designed so that when a patient diagnosed with sepsis is hospitalized at one of the clinical trial sites, they are assessed for the trial and with their consent or consent from a family member, are randomly selected to receive the vitamin/steroid cocktail or a placebo, in addition to clinical care provided by the treating team. The doctor, patient, and family members do not know whether the patient is receiving treatment or placebo until the end of the study. Patients are administered the combination therapy or a placebo for four days, or until discharged from the intensive care unit, whichever comes first.
The primary goals of the study are to demonstrate the efficacy of combination therapy in reducing the duration of cardiovascular and respiratory organ dysfunction or failure, as well as its ability to lessen 30-day mortality in critically ill patients with sepsis. The hope is that by involving so many hospitals in the trial, a large number of patients will be recruited in short order, and the results will be compiled quickly.
"Getting a clinical trial done within one year, which is our goal, is actually lightning fast," says Dr. Coopersmith. "Ultimately, we're aiming for enrolling 500 patients. But, once 200 have been enrolled, an independent group of researchers will look at the data to see whether there's a big difference between the patients who got the vitamins and those who got the placebo. If there's a huge effect, the trial will be stopped prior to the 500."