Sepsis Clinical Trial
Official title:
Open-label, Randomized, Controlled, With Blind Assessor, Study to Assess Efficacy and Safety of Rheosorbilact®, Solution for Infusion, in Comparison With Ringer's Lactate, Solution for Infusion, in a Complex Therapy of Sepsis.
This study evaluates the efficacy and safety of Rheosorbilact®, solution for infusion ("Yuria-Pharm" LLC), in comparison with Ringer's Lactate, solution for infusion, in a complex therapy of sepsis. Half of participants will receive Rheosorbilact® in complex therapy, while the other half will receive Ringer's Lactate in complex therapy.
Rheosorbilact® has rheological, anti-shock, detoxification, and alkalizing effects. Sorbitol
and sodium lactate are the major pharmacologically active ingredients. In the liver, sorbitol
is first converted into fructose, which is then converted into glucose, and then into
glycogen. Part of sorbitol is used for urgent energy needs, while the other part is kept as a
reserve in the form of glycogen. Isotonic sorbitol solution has a disaggregating effect and,
therefore, improves microcirculation and tissue perfusion.
The management of metabolic acidosis with sodium lactate goes more slowly compared to
bicarbonate solution, as far as sodium lactate enters the metabolic process; however the
latter does not cause swings in pH values. The effect of sodium lactate is typically seen 20
to 30 minutes after administration.
Sodium chloride is a plasma-substituting agent that exhibits a detoxification and rehydration
effect. It replenishes the deficiency of sodium and chlorine ions in various pathological
conditions.
Calcium chloride replenishes deficiency of calcium ions. Calcium ions are essential in the
transmission of nerve impulses, contraction of skeletal and smooth muscles, myocardial
activity, bone tissue formation, and blood clotting. It reduces the permeability of cells and
vascular walls, prevents the development of inflammatory reactions, enhances the resistance
of the body to infections and can significantly boost phagocytosis.
Potassium chloride restores the water-electrolyte balance. It exhibits a negative chrono- and
bathmotropic action and, when administered in high doses, has a negative ino- and dromotropic
and moderate diuretic effect. It is involved in the process of nerve impulse conduction,
increases the content of acetylcholine and causes excitation of the sympathetic segment of
the autonomic nervous system and improves the contraction of skeletal muscles in subjects
with muscular dystrophy or myasthenia.
Rheosorbilact® is administered to improve capillary blood flow for the prevention and
treatment of traumatic, surgical, hemolytic, toxic and burn shock, acute blood loss, and burn
disease; infectious diseases accompanied by intoxication, exacerbation of chronic hepatitis;
sepsis, pre- and postoperative period to improve arterial and venous circulation for the
prevention and treatment of thrombosis, thrombophlebitis, endarteritis, and Raynaud's
disease.
Ringer's Lactate, solution for infusion will be used as a comparator. As a rehydrating agent,
Ringer's Lactate has a detoxification effect, replenishes the deficiency of circulating blood
volume, and stabilizes the water and electrolyte composition of blood. Ringer's Lactate
normalizes the acid-base balance. Lactate is metabolized in the body to bicarbonate, so the
solution has an alkalizing effect. With osmolarity at 273 mOsm/l, Ringer's Lactate is close
to isotonic solution and is indicated for hypovolemia, isotonic dehydration, and metabolic
alkalosis.
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