6/29/23, 11:44 PM SMART-MED and SMART-SURG Pathway Feedback Search Clinical Topics Home Studies SMART MED and SMART SURG SMART MED and SMART SURG Disease Disease Sepsis and septic shock Traumatic brain injury Trial question What is the effect of balanced crystalloids for intravenous fluid administration in critically ill adult patients? Study design Multi-center Open label RCT Population Characteristics of study participants 42.0% female N = 15802 58.0% male 15802 patients (6705 female, 9097 male) Inclusion criteria: critically ill adult patients requiring intravenous fluid administration Key exclusion criteria: age < 18 years old Interventions N=7942 balanced crystalloids (either lactated Ringer's solution or Plasma-Lyte A) N=7860 saline (0.9% sodium chloride) Primary outcome Rate of major adverse kidney event within 30 days 15.4 15 4 % 14 3 https://web.pathway.md/studies/recHwhXTuRTcpTO6t 1/2 6/29/23, 11:44 PM 15.4 % SMART-MED and SMART-SURG Pathway 5 14.3 11.6 % 7.7 % Significant decrease 3.9 % NNT = 91 0.0 % Balanced crystalloids Saline Significant decrease in the rate of major adverse kidney event within 30 days (14.3% vs. 15.4%; aOR 0.9, 95% CI 0.82 to 0.99) Secondary outcomes No significant difference in new RRT (2.5% vs. 2.9%; aOR 0.84, 95% CI 0.68 to 1.02) No significant difference in persistent renal dysfunction (6.4% vs. 6.6%; aOR 0.96, 96% CI 0.84 to 1.1) Safety outcomes No significant differences in change in creatinine levels, death in the hospital before 60 days. Conclusion In critically ill adult patients requiring intravenous fluid administration, balanced crystalloids were superior to saline with respect to the rate of major adverse kidney event within 30 days. Reference Semler MW, Self WH, Wanderer JP et al. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):829-839. Open reference URL https://web.pathway.md/studies/recHwhXTuRTcpTO6t 2/2