Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Pneumonia
Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Pneumonia
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 pneumonia. 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.
Inclusion Criteria:

 1. Men and women aged 18 to 45 years inclusive;

 2. Community-acquired pneumonia with a prescription from the beginning of antibacterial
 therapy no more than 48 hours;

 3. The risk class of pneumonia in the PSI/PORT index score is at least IV;

 4. Informed consent for participation in the study signed by subject's own hand.

 5. The baseline value of the SOFA scale ≥ 2 points.

 Non-inclusion criteria:

 1. Individual intolerance of the components of the study drug and reference preparation;

 2. Hypersensitivity to sodium lactate;

 3. Intravenous infusions of lactate- or sorbitol-containing products within 24 hours
 before enrollment;

 4. Severe renal dysfunction (creatinine is more than 300 μmol/l or estimated creatinine
 clearance is less than 30 ml/min);

 5. Pregnancy or breast-feeding;

 6. Metabolic alkalosis;

 7. Severe metabolic acidosis;

 8. Intracerebral hemorrhage;

 9. Any thromboembolism;

 10. Decompensated cardiovascular failure;

 11. Arterial hypertension III st;

 12. Conditions associated with immunodeficiency (the use of cytostatics or system
 steroids, AIDS, diabetes mellitus);

 13. Extracellular hyperhydration or hypervolemia;

 14. Severe renal insuffiency (with oliguria/anuria);

 15. Hyperkalemia;

 16. Hypercalcemia;

 17. Ascites associated with cirrhosis;

 18. Conditions associated with increased lactate levels (hyperlactatemia > 2 mmol / l),
 including lactic acidosis, or impaired lactate uptake (including due severe hepatic
 insufficiency);

 19. Concomitant therapy with cardiac glycosides.

 Exclusion Criteria:

 1. Infusion of the study drug or the comparator is started more than 12 hours after
 randomization;

 2. Lack of data for community-acquired pneumonia (diagnosis not confirmed);

 3. Withdrawal of the informed consent by the subject;

 4. Investigator considers that the infusion therapy with either study drug or comparator
 may not be continued for safety reasons;

 5. Development of conditions that prevent further use of the study drug/comparator before
 efficacy evaluation visit (Visit 3);

 6. Subject needs concomitant therapy prohibited in the study before efficacy evaluation
 visit (Visit 3);

 7. Development of conditions (including serious adverse events) which make it impossible
 to evaluate the primary endpoint;

 8. Confirmation of pregnancy at any time of the study.