Large clinical trial shows both common septic shock fluids are equal

A randomized clinical trial conducted across five countries in 47 pediatric emergency departments, including Ann & Robert H. Lurie Children's Hospital in Chicago, established that both commonly used IV fluids for treating septic shock – balanced crystalloid fluid and 0.9% saline – are equally safe and effective. Results were published in the New England Journal of Medicine.

Septic shock is a life-threatening medical emergency in which the body's extreme response to infection causes organ failure. Treatment with IV fluids, either balanced crystalloid fluid (which mimics blood composition) or 0.9% saline, is used for resuscitation. Previous smaller studies have shown mixed results as to whether balanced fluid is more beneficial, especially for the kidneys, than saline.

Our study provides a definitive answer that there is no additional benefit or harm from using one type of IV fluid over another for septic shock resuscitation in children. We found no difference in outcomes, such as major adverse kidney event or persistent kidney dysfunction at 30 days. This is great news, since centers around the world can now confidently use whichever of these IV fluids is readily available."

Elizabeth Alpern, MD, MSCE, study co-author, Division Head of Emergency Medicine at Lurie Children's and Professor of Pediatrics, Northwestern University Feinberg School of Medicine

Over 9,000 children, aged 2 months to less than 18 years, with suspected septic shock were enrolled in the study.

Since obtaining standard informed consent prior to participation is not always feasible in an emergency, researchers engaged the community for input while still developing the study. Focus groups were held with parents of children at highest risk for sepsis, such as patients with cancer, immune deficiencies and other complex conditions. At Lurie Children's, the Family Advisory Board and Kids Advisory Board were involved. Families with children in the emergency department and pediatric intensive care unit were surveyed, and feedback from the general community was solicited online and via posters at the hospital. Families were able to opt out of the study in advance.

"It was very important to us to make sure that parents and patients understood what we were trying to accomplish, and that we heard and addressed any possible concerns prior to launching this study," said Dr. Alpern. "We greatly appreciate their collaboration and are pleased to share our results. Now we can move on from the debate about what kind of fluid is best and focus on new ways to improve care for kids with septic shock."

Dr. Alpern holds the George M. Eisenberg Professorship in Pediatrics.