Acetate Ringer's solution versus 0.9% saline for septic patients: study protocol for a multi-center parallel controlled trial

Fang Liu, Jing Zhang, Yuan Zhu, Lianjiu Su, Yiming Li, Li He, Li Yu, Zhiyong Peng, Fang Liu, Jing Zhang, Yuan Zhu, Lianjiu Su, Yiming Li, Li He, Li Yu, Zhiyong Peng

Abstract

Background: Previous study drew different conclusions on significant differences between saline and balanced crystalloid solution infused in critical illness but both showed a statistical difference in the sepsis subgroup. 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 renal outcomes are related to the underline acute kidney injury (AKI) severity and total volumes of infusion.

Methods/design: The investigators designed a pragmatic, multi-center parallel controlled trial recruiting 312 patients who are diagnosed with 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 enrolment 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 within 28 days (MAKE28), including the composite of in-hospital death, receipt of new renal replacement therapy, or persistent renal dysfunction. Secondary outcomes include 28-day 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 NCT03685214 . Registered on August 15, 2018.

Keywords: Acetate Ringer’s solution; Acute kidney injury; Saline; Sepsis; Septic shock.

Conflict of interest statement

None declared.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. Baseline variables include baseline renal function, main diagnosis and complications, severity of illness at enrolment, demographic characters, and admission location. Intravenous fluid includes saline, acetate Ringer’s solution, and other fluids. Receipt of invasive support includes mechanical ventilation, receipt of RRT, and vasopressors. Clinical outcomes include vital status, vasopressor days, mechanical ventilation days, RRT days, ICU stay days, hospital length of stay and serum creatinine at hospital discharge
Fig. 2
Fig. 2
Study flow. Abbreviations: RRT, renal replacement therapy; AKI, acute kidney injury; HUS, hemolytic uremic syndrome; ICU, intensive care unit

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