Balanced Crystalloids Versus Saline in Sepsis: A Secondary Analysis of the SMART Trial.

RATIONALE Administration of intravenous crystalloid solutions is a fundamental therapy for sepsis, but the effect of crystalloid composition on patient outcomes remains unknown. OBJECTIVES To compare the effect of balanced crystalloids versus saline on 30-day in-hospital mortality among critically ill adults with sepsis. METHODS Secondary analysis of patients from the Isotonic Solutions and Major Adverse Renal Events Trial (SMART) admitted to the medical intensive care unit with an ICD-10-CM code for sepsis, using multivariable regression to control for potential confounders. MEASUREMENTS AND MAIN RESULTS Of 15,802 patients enrolled in SMART, 1,641 patients were admitted to the medical intensive care unit with a diagnosis of sepsis. A total of 217 patients (26.3%) in the balanced crystalloids group experienced 30-day in-hospital morality, compared with 255 patients (31.2%) in the saline group (adjusted odds ratio, 0.74; 95% confidence interval, 0.59 - 0.93; P = 0.01). Patients in the balanced group experienced a lower incidence of major adverse kidney events within 30 days (35.4% vs 40.1%; aOR 0.78; 95% CI 0.63 - 0.97) and a greater number of vasopressor-free days (20 ± 12 vs 19 ± 13; aOR 1.25; 95% CI 1.02 - 1.54) and renal replacement therapy-free days (20 ± 12 vs 19 ± 13; aOR 1.35 [1.08 - 1.69]), compared to the saline group. CONCLUSIONS Among patients with sepsis in a large randomized trial, use of balanced crystalloids was associated with a lower 30-day in-hospital mortality compared to use of saline. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT02444988.

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