Welcome our newly activated sites: Henry Ford Health System, University of Florida at Jacksonville and Cleveland Clinic in Ohio
VICTAS is a clinical trial for hospitalized patients with sepsis, a life-threatening condition caused by a severe infection. Sepsis occurs when the body releases so much of certain chemicals into the bloodstream to fight the infection that it causes an overwhelming inflammatory response throughout the body. This reaction then damages major organs and tissues. Someone with sepsis is critically ill and they will commonly have a fever, a fast heart rate, a fast respiration rate and confusion but other symptoms of the infection may also be present. Sepsis is usually treated in an intensive care unit and patients may need oxygen or mechanical ventilation (an artificial lung machine), medications to raise their low blood pressure, or dialysis to remove toxins from their blood. There is a significant risk of death in sepsis patients so new ways of treating it are badly needed.
Sepsis is usually treated with antibiotics and intravenous fluids. Certain medications, such as “anti-inflammatory” steroids like hydrocortisone, have been tested many times. Recently, a researcher reported that a combination of medications may be more effective than any of them by itself. They reported that injecting high doses of vitamin C in combination with thiamine (vitamin B1) and hydrocortisone reduces the damage to major organs and increases the likelihood of surviving a severe episode of sepsis. These therapies are experimental and have not been tested in large numbers of patients nor approved by the Food & Drug Administration (FDA). So, doctors do not know for sure that these therapies work or that they are safe enough to be used in large numbers of people. Early results look promising, but doctors must first perform a type of research called a clinical trial in order to collect data from lots of people before they can know for sure.
VICTAS is a clinical trial to test the combination of Vitamin C, thiamine and hydrocortisone for the treatment of sepsis.. It will be conducted across 30 to 40 major academic medical centers in the United States and will enroll at least 500 patients. All patients in the clinical trial will receive the regular best intensive care available for sepsis, and half of the patients will additionally receive vitamin C, thiamine and hydrocortisone. By testing a large number of patients, the doctors can then see if the group of patients that got the combination of medications did better than the group that did not.
These drugs will be given via an IV every six hours for a total of 96 hours. The doctors participating in this trial are located in the ER and ICU departments at several large hospitals across the United States. They will be collecting information about the use of vasopressors (drugs that increase blood pressure), respiratory support (treatments to aid breathing) and the status of the patients at 30 days and up to one year after treatment. Patients must be adults, non-pregnant, and meet certain requirements to be in the trial so that the doctors can do a proper comparison between the two groups.
Currently, clinical sites are being activated and the VICTAS trial has started to enroll subjects. More information and updates about this clinical trial will be posted here and at clinicaltrials.gov.