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Compliance with a relaxed "care bundle" was associated with lower 30-day mortality and shorter median hospital stays among children with sepsis, according to interim data from the Improving Pediatric Sepsis Outcomes (IPSO) FACTO trial.

The relaxed, or liberalized, sepsis bundle -- i.e., a group of best evidence-based interventions -- involved delivering an initial fluid bolus within 60 minutes, as opposed to 20 minutes; and delivering antibiotics within 180 instead of 60 minutes. The bundle also involved accepted sepsis recognition protocols (screen, , or care order).

The trial data, presented at the virtual , involved approximately 40,000 patients with IPSO-confirmed critical and non-critical sepsis or suspected sepsis treated at children's hospitals across the U.S. from 2017 through 2019.

Better outcomes were seen with the relaxed bundle compared with the more time-restrictive original bundle, when medical personnel were bundle compliant, said Raina M. Paul, MD, of Advocate Children's Hospital in Park Ridge, Illinois, who reported the data.

Sepsis-attributable mortality declined by 48.9% among the liberalized bolus-compliant versus non-compliant group (3.1% vs 3.5%, P=0.233), and by 13.7% in original bundle-compliant vs non-compliant cases.

Adherence to all aspects of the liberalized bundle was associated with a reduction in median days in hospital from 9 to 6 days (33.3% reduction), Paul noted.

She explained that the is made up of 58 children's hospitals working together to improve pediatric sepsis identification, treatment, and outcomes. Key IPSO goals involve timely treatment of infection to avoid sepsis or septic shock, the specific and timely recognition of sepsis, timely treatment and de-escalation of treatment, and effective patients and family engagement.

The interim analysis of the IPSO FACTO data was among several pediatric sepsis study findings presented at the congress. Paul said that IPSO had recognized, based on very recent evidence, that a more liberalized bundle was improving outcomes.

Bundle compliance improved over time for both IPSO critical sepsis patients and suspected sepsis cases, but compliance fell far short of the target in both groups, largely due to delays in fluid bolus delivery, she said. "We have shown small improvements in compliance with this bundle, and we are hoping for more highly reliable care as we move forward."

Lauren Sorce, PhD, RN, of Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children's Hospital of Chicago, who was not involved with the study, told MedPage Today that the interim findings add to the growing evidence showing the benefits of medical care bundling in sepsis treatment.

"It's hard to argue with results from 40,000 patients," she said. "When these patients received bundle-compliant care mortality went down and median hospital days went down as well."

Each year, roughly 80,000 children are hospitalized with sepsis in the United States, and about 5,000 die of the condition. In addition, 25-40% of children who survive sepsis have long-term health issues related to their illness, according to figures from the Children's Hospital Association.

In another presentation at the congress, Kayla Bronder Phelps, MD, of C.S. Mott Children's Hospital in Ann Arbor, Michigan, reported the results of a study that found slightly longer hospital stays among children with sepsis who live in low-income neighborhoods.

She and her team analyzed data from the on more than one million children hospitalized in 2016 and 2017, identifying 10,130 with severe sepsis.

When the investigators grouped the pediatric sepsis patients by ZIP code quartiles, they found that children living in the lowest-income quartile stayed in the hospital an extra day, compared with those living in the highest-income quartile.

Hospitalizations for severe sepsis were highest among the lowest-income quartile (30.1%) and lowest in the highest-income quartile (17.1%), reflecting the fact that more children in the U.S. live in low-income than high-income neighborhoods, Bronder Phelps noted.

Overall, 851 children in the cohort (8.4%) died of sepsis during hospitalization, and no association was seen between death rates and income level. Children living in the lowest-income areas spent a median of 9 days in the hospital, compared with 8 days for children in the highest-income areas.

Bronder Phelps noted that the study is among the first to examine the impact of poverty on pediatric sepsis outcomes. She added that poverty has been shown to be a risk factor for a wide range of pediatric diseases, such as neonatal bacterial infection, asthma, and migraine, and in studies in adults, poverty has been shown to be associated with poorer outcomes, including increased mortality.