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. Some patients may need oxygen or mechanical ventilation (an artificial lung machine) or sometimes 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 intravenous fluids and antibiotics. Drugs called corticosteroids (anti-inflammatory "steroids" like hydrocortisone). Recently, a researcher discovered that when vitamin C is injected into the bloodstream of someone with sepsis, it seems to help calm the body's response to inflammation. Since then, several other physicians have started to explore this possible treatment and have even started adding other things like an amino acid called thiamine which is also called vitamin B1. 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 do a type of research called a clinical trial so that they can collect data from lots of people before they can know for sure.
VICTAS is a clinical trial to test the combination of Vitamin C and Thiamine for the treatment of sepsis. It will be conducted across 20 to 30 academic medical centers and will enroll at least 500 patients. All patients in the clinical trial will get intensive care and treatment with a steroid. Half of the patients will also get vitamin C and thiamine. By testing a large number of patients, the doctors can then see if the group of patients that got the vitamins do 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 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 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, the VICTAS trial is in a planning stage. More information about this clinical trial will be posted here and at clinicaltrials.gov once the trial is launched.