Background: The previous study demonstrated that there were no significant differences between saline and balanced crystalloid solution infused in critical illness. However, the sepsis subgroup analysis showed the statistical difference. Thus, we will specifically focus on septic patients in this study to compare the effects of saline and balanced solution. We hypothesize that effects of saline on acute kidney injury (AKI) are related to the underline AKI severity and total volumes of infusion.
Methods/design: The investigators designed a pragmatic, multi-centered crossover trial recruiting 312 patients who are diagnosed as sepsis/septic shock in the intensive care unit (ICU) and will be assigned with either acetate Ringer's solution or saline in the corresponding month. Patients with an end-stage renal disease (ESRD) or who need renal replacement therapy (RRT) prior to or at the time of enrollment are excluded. Enrolled patients will be regarded as with mild, moderate or severe sepsis on the basis of the severity of their illness, and will be divided into subgroups according to their initial renal function and various intravenous infusion volumes when being analyzed. The primary outcome is major adverse kidney events (MAKE), including the composite of in-hospital death, receipt of new renal replacement therapy, or persistent renal dysfunction. Secondary outcomes include 28 days-mortality, internal environment disturbance, incidence and duration of vasoactive drug treatment, duration of mechanical ventilation, duration of RRT and ICU and hospital length of stay. Results and Conclusions: To our knowledge, this study will be the first to focus on septic patients and provide credible and evident data on the comparison of outcome between acetate Ringer’s solution and saline for intravenous infusion in adult septic patients on the basis of baseline renal function and infusion volumes taken into consideration.
Trial registration: ClinicalTrials.gov, identifiers: NCT03685214. Registered on August 15, 2018. https://clinicaltrials.gov/ct2/show/NCT03685214 Keywords: sepsis; septic shock; acute kidney injury; saline; acetate Ringer's solution.