Balanced solution no better than saline solution for reducing mortality in ICU patients: JAMA
Brazil: Treatment with a balanced solution versus 0.9% saline solution did not significantly reduce 90-day mortality among critically ill patients needing fluid challenges, finds a recent study.
The findings, published in the Journal of the American Medical Association (JAMA), do not support the use of this balanced solution.
Intravenous (IV) fluids are used routinely in critically ill patients to replenish or sustain intravascular volume and to deliver drug infusions. Saline solution (0.9% sodium chloride) has remained the primary fluid over time. However, recent evidence has shown that the administration of balanced crystalloids (ie, crystalloids whose sodium and chloride concentrations are similar to plasma) resulted in better outcomes. Clinical and laboratory studies have questioned whether specific fluid types result in improved outcomes, including mortality and acute kidney injury.
Against the above background, Fernando G. Zampieri, HCor Research Institute, São Paulo, Brazil, and colleagues aimed to determine the effect of a balanced solution vs saline solution (0.9% sodium chloride) on 90-day survival in critically ill patients in the Balanced Solutions in Intensive Care Study (BaSICS) trial. The trial is a double-blind, factorial, randomized clinical trial conducted across 75 ICUs in Brazil.
The study included patients who were admitted to the ICU with at least 1 risk factor for worse outcomes, who required at least 1 fluid expansion, and who were expected to remain in the ICU for more than 24 hours were randomized between May 29, 2017, and March 2, 2020; follow-up concluded on October 29, 2020. 11 052 patients were randomized in the ratio of 1:1 to receive either a balanced solution (n = 5522) or 0.9% saline solution (n = 5530) for all intravenous fluids.
The primary outcome was 90-day survival.
The research yielded the following findings:
- There was no significant interaction between the 2 interventions (fluid type and infusion speed).
- Planned surgical admissions represented 48.4% of all patients.
- Of all the patients, 60.6% had hypotension or vasopressor use and 44.3% required mechanical ventilation at enrollment.
- Patients in both groups received a median of 1.5 L of fluid during the first day after enrollment.
- By day 90, 26.4% assigned to a balanced solution died vs 27.2% assigned to saline solution (adjusted hazard ratio, 0.97).
- There were no unexpected treatment-related severe adverse events in either group.
"Our findings showed that among critically ill patients requiring fluid challenges, use of a balanced solution compared with 0.9% saline solution did not significantly reduce 90-day mortality," wrote the authors. "The findings do not support the use of this balanced solution."
Reference:
The study titled, "Effect of Intravenous Fluid Treatment With a Balanced Solution vs 0.9% Saline Solution on Mortality in Critically Ill Patients: The BaSICS Randomized Clinical Trial," is published in JAMA.
DOI: https://jamanetwork.com/journals/jama/fullarticle/2783039
