Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Sepsis.
Condition: Sepsis; Intoxication; Septic
MeSH terms: Sepsis; Toxemia
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Rheosorbilact®; Ringer lactate
Intervention type(s): Drug; Drug
Intervention description(s): Administered intravenously (with speed 40-60 drip per minute) at a dose of 600 to 1,000 ml (10 to 15 ml/kg body weight per 24 hours) for 3 days.; Administered intravenously (with speed 40-60 drip per minute) at a dose of 1,000 to 2,500 ml (15 to 40 ml/kg body weight per 24 hours) for 3 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment