ACETATE RINGER'S SOLUTION VERSUS NORMAL SALINE SOLUTION IN SEPSIS: A RANDOMIZED, CONTROLLED TRIAL

Abstract

Background: Normal saline solution (NSS) and Ringer's acetate solution (RAS) are commonly given to critically ill patients as a fundamental fluid therapy. However, the effect of RAS and NSS on sepsis patient outcomes remains unknown. Methods: We conducted a single-center prospective open-label parallel controlled trial to enroll adult patients (>18 years old) diagnosed with sepsis. Participants received either RAS or NSS for intravenous infusion for 5 days. The primary outcome was the incidence of major adverse kidney events within 28 days (MAKE28). Secondary outcomes included 30-/90-day mortality, acute kidney injury, and hyperchloremia. The patients were then reclassified as NSS-only, RAS-only, and RAS + NSS groups according to the type of fluid they had received before enrollment. Thereafter, a secondary post hoc analysis was performed. Results: Two hundred fifty-five septic patients were screened, and 143 patients (51.0% in RAS group and 49.0% in NSS group) were enrolled in the study. Each group received a median of 2 L of fluid administration during five interventional days. Of the patients, 39.3% had received 500 mL (500-1,000 mL) of balanced salt solutions (BSSs) before intensive care unit (ICU) admission. There was no statistical difference among the RAS and NSS group on the primary outcome MAKE28 in the initial analysis (23.3% vs. 20.0%; OR, 1.2 [0.6 to 2.2]; P = 0.69). MAKE28 was observed in 23.3% of RAS-only versus 27.3% of NSS-only group patients (0.82 [0.35-1.94], P = 0.65) in the secondary post hoc analysis. The patients in the NSS-only group had a longer invasive mechanical ventilation days and a trend toward the accumulation of serum chloride. Conclusion: This study observed no statistically significant difference on MAKE28 and secondary outcomes among sepsis patients receiving RAS and NSS. However, it is unclear whether the large amount of fluid resuscitation before ICU admission and carrier NSS narrowed the difference between BSSs and NSSs.

Trial registration: ClinicalTrials.gov NCT03685214.