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TOPLINE: 

A large, randomized trial of more than 8400 children with suspected septic shock found that balanced fluids did not reduce kidney complications, mortality, or hospital stay compared with saline, though they were associated with lower rates of hyperchloremia.

METHODOLOGY: 

• Researchers conducted a multicenter, pragmatic, open-label trial including 8482 children (median age, 6.8 years; 50.8% boys) with suspected septic shock and abnormal perfusion.
• Patients were randomly assigned to receive balanced crystalloid fluid (lactated Ringer's, Plasma‑Lyte, or Hartmann's; n = 4235) or 0.9% saline (n = 4247) for bolus and maintenance fluids for up to 48 hours.
• The primary outcome was major adverse kidney events within 30 days after enrollment or hospital discharge. The secondary outcomes included the length of hospital stay, hospital-free days within 28 days after enrollment, and all-cause death before discharge and within 90 days after randomization.

TAKEAWAY:

• Major adverse kidney events occurred in 3.4% of patients in the balanced-fluid group and in 3.0% in the 0.9%-saline group (risk ratio [RR] , 1.10; 95% CI, 0.88-1.40; P = .85).
• The median number of hospital-free days within 28 days were 23 in both treatment groups, with no difference in death before hospital discharge (1.1% each) or within 90 days (2.3% vs 2.1%).
• Hyperchloremia (31.4% vs 49.0%) and hypernatremia (1.8% vs 3.1%) occurred less frequently in the balanced-fluid group than in the 0.9%-saline group.
• Hyperlactatemia occurred more frequently with balanced fluid than with 0.9% saline (19.8% vs 16.7%), with no between-group differences in thrombosis, cerebral edema, or other adverse events.

IN PRACTICE:

"In this pragmatic, randomized clinical trial involving approximately 9000 children with suspected septic shock treated with fluid resuscitation for abnormal perfusion in an emergency department, the incidence of death, new renal replacement therapy, or persistent kidney dysfunction (the composite primary outcome) was not significantly different between treatment with balanced fluid and treatment with 0.9% saline," the authors concluded.

SOURCE:

The study was led by Fran Balamuth, MD, PhD, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania. It was published online on April 24 in The New England Journal of Medicine.

LIMITATIONS:

Limitations included limited generalizability to low-resource settings and hospital-acquired sepsis, a low primary event rate that reduced statistical power, inability to confirm subgroup benefits in more severe cases, higher-than-expected withdrawal rates, unmeasured fluid exposure after 48 hours, and inability to identify repeat enrollments.

DISCLOSURES:

The study received funding through grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Diabetes and Digestive and Kidney Diseases, the Commonwealth of Pennsylvania Department of Health, and several other agencies and research institutes in the United States, Canada, and Australia. Some authors reported receiving research grants or funding or having other ties with various pharmaceutical companies. Full disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.