There were no significant differences in 90-day mortality rates between two common treatment strategies for sepsis, according to results from a randomized, non-blinded, phase 3 clinical trial published in the New England Journal of Medicine.
The trial assessed the 90-day survival rates and other measures of recovery, such as length of hospital stay, among adults assigned to a restrictive or liberal fluid-management treatment strategy for a sudden drop in blood pressure due to sepsis.
The Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) trial was a randomized clinical trial conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) network and funded by the National Heart, Lung, and Blood Institute (NHLBI).
Enrollment in the trial ended in February 2022 due to a lack of significant difference observed between the two 24-hour strategies. After a scheduled interim analysis on Feb. 2, 2022, an independent data and safety monitoring board found that outcomes were similar in both arms and that further enrollment was unlikely to change the result. They also found no concerns regarding patient safety.
The researchers noted that the findings are important since they show that both approaches to treating sepsis have similar outcomes. They will continue patient follow-up according to the protocol, including the completion of data collection on all patients already enrolled in the trial. Formal analyses of study data are underway and findings are forthcoming. Researchers plan to share findings from the trial through presentations at scientific meetings and by publishing results from the study in peer-reviewed journals.