The first results of the international multicenter clinical study RheoSTAT-CP0669 on the effectiveness and safety of infusion solution Rheosorbilact® in the complex treatment of patients with burns

Abstract

Mechanization and urbanization are accompanied by an increase in the prevalence of burns. A burn causes both local damage and systemic inflammatory response that leads to inadequate oxygen delivery to vital organs and inadequate elimination of metabolites. Infusion therapy for burns aims to restore perfusion and prevent ischemia. The implementation of effective dynamic schemes of infusion therapy has led to a decrease in mortality, however, an excessive amount of injected fluid does not improve the patient’s volumetric status, instead increasing tissue swelling and causing a number of complications. Therefore, doctors are faced with the question of choosing the optimal infusion therapy, which will allow maintaining the patient’s status at the needed level called normovolemia. According to the results of the open, blinded evaluation of the randomized controlled trial RheoSTAT-СР0669, administration of Rheosorbilact to patients with burns by intravenous infusion at a dose of 200-400 ml/day for 3 days significantly improves the clinical condition, reduces the manifestations of (poly-) organ failure and endogenous intoxication. Small-volume infusion therapy with Rheosorbilact causes a statistically significant decrease in the breathing rate, a decrease in endogenous intoxication and the intensity of inflammation, as well as positive dynamics of the blood gas composition. Administration of the drug in this mode has a favorable safety profile: it does not lead to fluid overload, associated complications, or other serious undesirable side effects, and does not cause a clinically significant increase in blood lactate level. The RheoSTAT-СР0669 study substantiates the feasibility of using Rheosorbilact in the complex therapy of burns.