CLOVERS study to examine methods of increasing blood pressure in sepsis patients

Sepsis occurs when the body has a severe reaction to infection, that can become a life-threatening condition, and one of the major dangers for sepsis patients is low blood pressure. Researchers at the University of Cincinnati (UC) are involved in a national study comparing two methods of increasing blood pressure in those patients. The study could determine which treatment is more effective and as a result reduce the high mortality rates in sepsis patients.

Over 1.5 million people in the United States and 19 million worldwide get sepsis every year, according to Kristin Hudock, MD, assistant professor in the Division of Pulmonary, Critical Care and Sleep Medicine in the Department of Internal Medicine at the UC College of Medicine, and the UC site principal investigator on the study.

“We’re looking specifically at septic shock which is a more extreme version of sepsis,” says Hudock. “Depending on the source of the information, there is anywhere from 25 percent to 40 percent mortality in that patient population. It affects all kinds of people—seemingly healthy people, transplant patients, patients with malignancies or other immune-compromised states.”

The Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) study compares two standards of care for increasing blood pressure in patients with dangerously low blood pressure due to a suspected infection. One method is to first provide intravenous fluids to the patient, and then use drugs such as adrenalin (called vasopressors). The other method is to use the drugs first, and then use fluids.

The multi-center, prospective phase 3 randomized non-blinded interventional trial will enroll up to 2,230 subjects over three years from the Clinical Trials Network for the Prevention and Early Treatment of Acute Lung Injury (PETAL) network emergency departments including UC Medical Center. PETAL is a network of 12 clinical centers and one clinical coordinating center funded by the National Heart, Lung and Blood Institute. Approximately 50 hospitals, including Johns Hopkins, Harvard, Vanderbilt and the Cleveland Clinic are centers for this study.

“The involvement with the Department of Emergency Medicine has been an excellent collaboration,” says Hudock. “In Emergency Medicine (EM) they are on the front lines. EM teams are fantastic at triage and initial stabilization, while in Critical Care Medicine we have the time for a comprehensive approach, which allows us to step back, gather more information and treat long-term effects. We each have different areas of expertise that we bring to the table, and we have enjoyed learning from each other.”

Enrolled subjects will be given a treatment regimen of fluids first and then vasopressors or vice versa to treat their low blood pressure for the first 24 hours. The subjects are then followed up with 90 days later.

“I believe the CLOVERS study will determine which treatment strategy is best for our patients with sepsis,” says Hudock. “If we can help people get better more quickly, we can move the needle on sepsis-induced mortality. The key in sepsis is to provide enough blood flow to maintain organ function. The impact we hope CLOVERS will have is to help sepsis patients recover more quickly so they can go home sooner and enjoy their lives.”