A consumer advocacy organization is asking federal officials to halt a clinical study involving treatment for sepsis carried out by the Cleveland Clinic and other medical institutions across the country.
The group, Public Citizen, said the trial involving treatment for sepsis is deeply flawed and unethical.
Sepsis is the body's extreme response to an infection. It happens when an infection you already have triggers a chain reaction throughout your body, according to the Centers for Disease Control and Prevention. Without treatment, it can lead to rapid tissue damage, organ failure and death.
The Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) attempts to answer the best way to manage the condition.
During usual care for sepsis, doctors increase doses of IV fluids and blood-pressure-raising medications based on a patient's need. However, in this study, half of the patients will receive predominately IV fluids and the other half will receive predominately blood pressure-raising medications.
In a letter to the government, the group said there isn't a control group that is receiving the usual treatment for sepsis, which can't ensure the experiment isn't causing increased deaths and organ failure.
Beth Israel Deaconess Medical Center, the lead site of the clinical trial, released a statement that reads, in part:
This study compares two approaches for the treatment of septic shock that are both currently in widespread use. Our study will provide clinicians with authoritative data on which approach leads to better patient outcomes. The study protocol was designed by expert clinicians in emergency and critical care medicine representing nearly 50 hospitals in the United States and follows a well-accepted design. To ensure that the study meets the highest scientific and ethical standards, the study was thoroughly reviewed by an independent protocol review committee and a Data Safety and Monitoring Board appointed by the National Heart, Lung, and Blood Institute (the study’s funder), and a central Institutional Review Board, before the study began
Public Citizen said they found flaws in consent forms given to participating patients, including failure to explain to patients the risks of the two approaches conducted in the trial.
The trial is also scheduled to be held at Ohio State University Wexner Medical Center in Columbus and University of Cincinnati Medical Center.