The first data on international multicenter clinical study RheoSTAT-CP0620 on the efficacy and safety of Rheosorbilact® infusion in therapy of sepsis

Abstract

Sepsis stays a common and life-threatening pathological condition; hospital mortality in patients with sepsis exceeds 30 %. Fluid resuscitation is an important component of sepsis treatment. The purpose of this work was to evaluate the efficacy and safety of the multicomponent infusion solution Rheosorbilact in the treatment of patients with sepsis. The international multicenter randomized study RheoSTAT-CP0620 included 180 patients aged 18 to 60 years diagnosed with sepsis. Patients received Rheosorbilact therapy in dosage according to the package insert. A change in the SOFA score on day 3 of treatment was considered to be the primary endpoint. Changes in APACHE II, SAPS II, and MODS scores, as well as changes in endogenous intoxication markers on day 3 of treatment, were considered the secondary endpoints. The safety of the drug was assessed by analysis of adverse events and vital signs after 3 days of therapy. On day 3 of Rheosorbilact treatment, statistically significant changes in SOFA (by 2.01±1.37 points), APACHE II (by 4.24±3.76 points), SAPS II (by 3.40±5.30 points), and MODS (by 1.37±1.37 points) scales were recorded. In addition, there was a statistically significant improvement in markers of endogenous intoxication (urea, creatinine and total bilirubin concentrations, leukocyte counts, and calculated intoxication indices) on day 3 of treatment. The majority of adverse events (71.74 %) were mild. None of the adverse events were related to the study drug and did not result in the patient’s withdrawal from the study. According to the results of RheoSTAT-CP0620, Rheosorbilact is an effective and safe drug for the treatment of patients with sepsis. It is advisable to include Rheosorbilact in routine treatment algorithms for patients with sepsis.