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

Among intensive care patients requiring intravenous fluid challenges, does the use of a balanced solution compared with saline solution (0.9% sodium chloride) improve 90-day survival? In this randomized clinical that included 10 520 patients in intensive care units, intravenous fluid bolus treatment with a balanced solution vs saline solution resulted in 90-day mortality of 26.4% vs 27.2%, respectively, a difference that was not statistically significant.

Intravenous fluids are routinely used in critically ill patients to sustain or replenish intravascular volume and to deliver drug infusions. Although saline solution (0.9% sodium chloride) has remained the primary fluid over time, recent evidence from observational studies and 2 large unblinded cluster-randomized, single-center trials in the US demonstrated that administration of balanced crystalloids (ie, crystalloids whose sodium and chloride concentrations are similar to plasma) resulted in better outcomes. Furthermore, this effect may be mediated by smaller changes in serum chloride levels. However, these results are not uniform across clinical trials, and insufficient evidence is available from large individual randomized multicenter studies. The Balanced Solutions in Intensive Care Study (BaSICS), a double-blind, factorial, randomized clinical trial was conducted to assess whether administration of a balanced solution (Plasma-Lyte 148) during intensive care unit (ICU) stay, compared with saline solution, would result in improved 90-day survival in critically ill patients. A total of 11 052 patients were randomized between May 29, 2017, and March 2, 2020, at 75 ICUs. There were 532 patients who were excluded from the analysis (486 patients subsequently refused to provide consent and 46 were duplicate patients [the first enrollment for those patients was kept in the analysis]), leaving 10 520 patients for the analysis (5230 patients randomized to a balanced solution and 5290 randomized to saline solution). Follow-up concluded on October 29, 2020. The patient characteristics were well-balanced between the groups (mean age, 61.1 [SD, 17] years; 44.2% were women). Of all the patients, 48.4% were admitted to the ICU after elective surgery and the majority were randomized during their first day in the ICU. Approximately 68% of all patients received a crystalloid fluid bolus before ICU admission (45% received >1 L). Of all patients, 60.6% had hypotension or vasopressor use and 44.3% required mechanical ventilation at enrollment. Read more...

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