Experience in the open multicenter randomized controlled trial of Rheo-STAT on the efficacy and safety of Reosorbilact in patients with sepsis

Abstract

Background. Elimination of intoxication syndrome is one of the main components of sepsis treatment. The Rheo-STAT study is an interventional open multicenter randomized controlled trial of the efficacy of Reosorbilact (“Yuria-Pharm”) in the treatment of intoxication syndrome. The study was conducted in 7 countries, patients of the sepsis subgroup were recruited in 5 of them (Ukraine, Moldova, Georgia, Kazakhstan, Uzbekistan). Objective. To determine the efficacy and safety of Reosorbilact in patients with sepsis. Materials and methods. The study involved 628 adult patients with sepsis, peritonitis, pneumonia and burns. The subgroup of sepsis consisted of 180 people (72 % males, mean age – 41.3 years), the most common comorbidities were cardiovascular diseases (24 %), diabetes mellitus (15 %), and infectious diseases (8 %). The inclusion criteria were the following: age 18-60 years, diagnosis of sepsis, established by the ACCP/SCCM criteria ≤24 hours before the initial visit, obtaining of the informed consent, baseline SOFA scale value ≥2. The primary endpoint was the total score on the SOFA scale on the 3rd day of treatment compared to the baseline value. The secondary endpoints included the change in the overall score according to the APACHE II, SAPS II, MODS, PSI/PORT, CURB-65 scales; changes in biochemical, immunological and integral markers of endogenous intoxication. Results and discussion. Low-volume infusion therapy with Reosorbilact (200-400 ml per day) resulted in an increase in circulating blood volume and a decrease in the total volume of infusions required without the risk of volume overload, which is especially important for critically ill patients. Exogenous lactate in Reosorbilact did not increase the content of endogenous lactate (1st day – 2.27 mmol/L, 3rd day – 1.63 mmol/L), which indicates the high safety of the solution. In the complex of intensive care administration of Reosorbilact helped to reduce hyperthermia (1st day – 38.2 °C, 3rd day – 36.8 °C, p<0.001), heart rate (1st day – 95.43 beats/min, 3rd day – 81.13 beats/min, p<0.001) and the number of leukocytes (1st day – 14.5×109/L, 3rd day – 8.8×109/L) as a marker of endogenous intoxication. During 3 days of therapy Reosorbilact also normalized the acid-base composition of the blood. Conclusions. 1. Elimination of intoxication syndrome is one of the main components of sepsis treatment. 2. Reosorbilact infusion therapy increases the volume of circulating blood without the risk of volume overload. 3. The inclusion of Reosorbilact in the complex treatment of sepsis after 3 days provides a decrease in body temperature, heart rate, white blood cell count and normalization of the acid-base composition of the blood.