A nationwide study of sepsis patients currently underway is deeply flawed and putting patients at risk, according to Public Citizen, a consumer advocacy organization.
The organization called the study, which is funded by the National Institutes of Health (NIH) and was designed at Harvard University, unethical and reckless in a letter to HHS published Aug. 28.
In the study, patients with sepsis—an extreme reaction to infection that kills more than 250,000 Americans every year—are taking one of two treatments for the condition that are not considered standard, Public Citizen stated. The study, called CLOVERS (Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis), treats patients in the first 24 hours of sepsis care and aims to determine the impact of restricting fluids to one group and giving drugs first compared to giving lots of fluids to another group.
The study will enroll up to 2,230 subjects from institutions from the Petal Network, a clinical trials network for the Prevention and Early Treatment of Acute Lung Injury.
The study has no control group receiving the standard amount of fluids. However, sepsis care doesn’t have a standard consensus, NPR reported. Still, Public Citizen called the treatments “highly unusual” and “risky.”
“The design of this disturbing trial is more akin to an experiment that would be conducted on laboratory animals,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said in a statement. “These human subjects are unwitting guinea pigs in a physiology experiment that will not advance medical care for sepsis and likely will harm many.”
Because the study is not treating any patients with the usual care, including adjusting the doses of intravenous (IV) fluids and blood pressure drugs based on the patient, researchers won’t actually be able to determine if the either of the experimental treatments is safe–or more effective.
“The misalignments in CLOVERS between individual patients’ needs and treatments being given as part of the experiment are far outside the norms of sepsis treatment,” Carome said. “It is obvious they carry an unacceptable increased risk of organ failure and death and should be avoided.”
Public Citizen also called out the review process for the trial, stating the fact that the study was reviewed at multiple levels and approved by officials at NHLBI . The group also said the Petal Network is a “troubling example of the dysfunction—at multiple levels—of the U.S. system for protecting human subjects enrolled in complex clinical trials.”
With the potential to be lethal quickly in patients, experimental treatments for sepsis that end up being harmful could add to organ failure and mortality, the group concluded.
“The Office for Human Research Protections plans to review the allegations," an HHS spokesperson told HealthExec.