Rheosorbilact® is administered as a part of the infusion therapy intravenously (with speed 40-60 drip per minute) at a dose of not more than 400 ml (6 to 7 ml/kg body weight per 24 hours). The period of the treatment with the study drug lasts 3 days.

Ringer's Lactate is administered as a part of the infusion therapy intravenously (with speed 40-60 drip per minute) at a dose of not more than 400 ml (6 to 7 ml/kg body weight per 24 hours).The period of the treatment with the active comparator lasts 3 days.

Pneumonia

Rheosorbilact® is administered as a part of the infusion therapy intravenously (with speed 40-60 drip per minute) at a dose of not more than 400 ml (6 to 7 ml/kg body weight per 24 hours) for 3 days.

Rheosorbilact®

Ringer lactate

"Unimedi Adjara" LLC

JSC EVEX Medical corporation/Kutaisi Referral Hospital

"Israel Georgian Medical Research Clinic HELSI Core LLC" LTD.

Hospital of the Medical Center Office of the President's Affairs Republic of Kazakhstan

Municipal Clinical Hospital "Sfinta Treime"

Municipal Clinical Hospital

National institute of phthisiology and pulmonology named after F.G. Yanovsky NAMS of Ukraine

City Hospital №1

Vinnitsa National Medical University; City Clinical Hospital №1

Republican Scientific Center of Emergency Medical Aid

198 Hospital

Thai Binh University of Medicine and Pharmacy

Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Pneumonia

Open-label, Randomized, Controlled, With Blind Assessor, Study to Assess Efficacy and Safety of Rheosorbilact®, Solution for Infusion ("Yuria-Pharm"), in Comparison With Ringer's Lactate,Solution for Infusion, in a Complex Therapy of Pneumonia.

Sequential Organ Failure Assessment (SOFA) score is composed of scores of six organ systems: R-respiratory, C-cardiovascular, H-hepatic, Co-coagulation, Re-renal, and N-neurological graded from 0 to 4 according to the degree of dysfunction or failure.
The SOFA score ranges from 0 to 24 points. We evaluate initial SOFA score and differences between subsequent scores (Δ-SOFA scores).

Acute physiology and chronic health evaluation（APACHE) II score is calculated from a patient's age (0-6 points) and 12 physiological parameters (each item 0-4 points): AaDO2 or PaO2 (depending on FiO2), Temperature (rectal), Mean arterial pressure, pH arterial, Heart rate, Respiratory rate, Sodium (serum), Potassium (serum), Creatinine, Hematocrit, White blood cell count, Glasgow Coma Scale and chronic disease health status (0-5 points).
The APACHE II score ranges from 0 to 71 points. We evaluate initial APACHE II score and differences between subsequent scores (Δ-APACHE II scores).

The SAPS II score is made of 17 variables: 12 physiology variables, age, type of admission (scheduled surgical, unscheduled surgical, or medical), and three underlying disease variables (acquired immunodeficiency syndrome, metastatic cancer, and hematologic malignancy).
The SAPS II score ranges from 0 to 160 points. We evaluate initial SAPS II score and differences between subsequent scores (Δ-SAPS II scores).

MODS (Multiple Organ Dysfunction Score) is composed of scores of six organ systems: R-respiratory, C-cardiovascular, H-hepatic, Co-coagulation, Re-renal, and N-neurological graded from 0 to 4 according to the degree of dysfunction or failure.
The MODS score ranges from 0 to 24 points. We evaluate initial MODS score and differences between subsequent scores (MODS scores).

The Pneumonia severity index (PSI or PORT Score) for predicting the mortality in patients with pneumonia based on patients stratification into five classes of risk for death.
The lowest risk class (risk class I) comprises patients who are younger than 50 years of age, have none of the five important coexisting illnesses and have normal mental status and normal or only mildly abnormal vital signs at presentation. Assignment to the remaining risk classes depends on the presence or absence of a set of medical history, physical examination, and laboratory findings.
Total point scores of 70 or less correspond to class II, 71-90 to class III, 91-130 to class IV, and more than 130 to class V.

The CURB-65 score for predicting the mortality in patients with pneumonia is an acronym for each of the six risk factors measured: confusion status, serum urea, respiratory rate, blood pressure, and age.
Each risk factor scores one point, for a maximum score of 5.

Concentration of glucose (mmol/L) in blood serum after 8-hour fasting.

Concentration of sodium (mmol/L) in blood serum after 8-hour fasting.

Concentration of potassium (mmol/L) in blood serum after 8-hour fasting.

Concentration of lactate (mmol/L) in blood serum after 8-hour fasting.

Concentration of pyruvate (mmol/L) in blood serum after 8-hour fasting.

Concentration of urea (mmol/L) in blood serum after 8-hour fasting.

Concentration of creatinine (µmol/L) in blood serum after 8-hour fasting.

Concentration of bilirubin (µmol/L) in blood serum after 8-hour fasting.

Concentration of alanine aminotransferase (U/L) in blood serum after 8-hour fasting.

Concentration of aspartate aminotransferase (U/L) in blood serum after 8-hour fasting.

Concentration of lactate dehydrogenase (U/L) in blood serum after 8-hour fasting.

Concentration of alkaline phosphatase (U/L) in blood serum after 8-hour fasting.

Concentration of γ-Glutamyltransferase (U/L) in blood serum after 8-hour fasting.

Concentration of low-molecular-weight adiponectin (U/L) in blood serum after 8-hour fasting.

Concentration of middle-molecular-weight adiponectin (U/L) in blood serum after 8-hour fasting.

Concentration of albumin in blood serum after 8-hour fasting.

Concentration of procalcitonin level (µg/L) in blood serum after 8-hour fasting.

White blood cells (billion/L) count level in blood serum after 8-hour fasting.

Lymphocyte count (%) level in blood serum after 8-hour fasting.

Platelet count level (billion/L) in blood serum after 8-hour fasting. 2. assessment of ECG parameters; 3.parameters of central hemodynamics; 4. mental status: consciousness, intelligence, behavior, neuromuscular disorders.

Calculated by dividing the number of myelocytes, young and stab neutrophils by number of segmented neutrophils.

Calculated by the formula of Kalf-Kalifa: correlation between the level of neutrophils and the content of other cells in the blood leukocytic composition.

Concentration of C-reactive protein (CRP) in blood serum after 8-hour fasting.

Level of Circulating immune complexes (CIC) in blood serum after 8-hour fasting.

Concentration of Interleukin-1 (pg/ml) and Interleukin-2 (pg/ml) in blood serum after 8-hour fasting.

Calculated by dividing the number of neutrophils (%) by number of lymphocytes (%).

Concentration of Ig A, Ig M and Ig G in blood serum after 8-hour fasting.

Concentration of complements (C3, C4) in blood sample after 8-hour fasting.

Measurement of central venous pressure (mmh2o) in the central vein.

The GCS is composed of 3 components: ocular response (assessment 1-4 points), motor response (assessment 1-6 points) verbal response (evaluation of 1-5 points). Scores for each component are added together to get the total that will range between a minimum of 3 points (which corresponds to a patient who does not open his eyes and no motor response to stimulation or verbal response) and a maximum value of 15 points (corresponding to a patient with open eyes, obeying orders and maintaining a consistent language).

Measurement of 12-lead ECG with further evaluation and interpretation whether the ECG waves, intervals, durations and rhythm are normal.

Number of participants with presence of clinical signs such as adynamia, weakness, memory impairment, sleep disorder, irritability, evaluated according to patient's subjective complaints.

Yuria-Pharm

Outcomes Assessor will perform the assessment of primary, secondary efficasy and safety parameters

Rheosorbilact® is administered as a part of the infusion therapy 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).The period of the treatment with the study drug lasts 3 days.

Ringer's Lactate is administered as a part of the infusion therapy 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).The period of the treatment with the active comparator lasts 3 days.

Peritonitis

Intoxication

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.

Kutaisi Referral Hospital

JSC EVEX/LTD Traumatology

Institute of Ambulance

Republican Clinical Hospital

Institute of General and Urgent Surgery of the National Academy of Medical Sciences of Ukraine

Kyiv City Clinical Hospital No.4; National Medical University named after O.O. Bogomolets

HSEE of Ukraine "Ukrainian Medical Stomatological Academy"; Poltava Central District Hospital

Republic Centre of Ambulance

Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Peritonitis

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 Peritonitis.

MPI (Mannheim Peritonitis Index) scoring system for predicting the mortality in patients with peritonitis based on analysis of 8 possible risks factors (age, sex, organ failure, cancer, duration of peritonitis, involvement of colon, extension of spread and character of peritoneal fluid)
The MPI score ranges from 0 to 47 points. We evaluate initial MPI score and differences between subsequent scores (MPI scores).

Concentration of creatine kinase (U/L) in blood serum after 8-hour fasting.

Platelet count level (billion/L) in blood serum after 8-hour fasting.

Concentration of Ig A, Ig M and Ig G in blood serum after 8-hour fasting

Burns

Karaganda State Medical University; Regional Center of Traumatology and Orthopedics named after Professor H.Zh.Makazhanov

Republic Clinical Hospital of Traumatology and Orthopedy

Kharkiv State Clinical Hospital of Ambulance

Kyiv City Clinical Hospital №2; Shupyk National Medical Academy of Postgraduate Education

Vinnytska Pyrohov's State Clinical Hospital

Republic Scientific Center of Ambulance

Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Burns

Open-label, Randomized, Controlled, With Blind Assessor, Study to Assess Efficacy and Safety of Rheosorbilact®, Solution for Infusion ("Yuria-Pharm"), in Comparison With Ringer's Lactate,Solution for Infusion, in a Complex Therapy of Burns

Spronck score is made of 5 main parameters: hemodynamic state (2 points), peripheral circulation (2 points), microvascular variables (1 point), systemic markers of tissue oxygenation (1 point), signs of organ dysfunction (2 points).
Spronk score ranges from 0 to 8 points. A score > 2 indicates the presence of shock. We evaluate initial Spronk score and differences between subsequent scores (Δ-Spronk scores).

Sepsis

Intoxication; Septic

Hospital of the Medical Center of the Administration of the President of the Republic of Kazakhstan

Dnipro`s Medical Academy of Ministry of Health of Ukraine

Zaicev's Institute of general and urgent surgery NMA Ukraine

Khmelnytskyi Regional Clinical Hospital

Central District Clinical Hospital

Zaporizka Medical Academy of postgraduate education, Zaporizkyi Clinical Hospital N9

Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Sepsis.

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.

White blood cells (billion/L) count level in blood serum after 8-hour fasting

Lymphocyte count (%) level in blood serum after 8-hour fasting

Platelet count level (billion/L) in blood serum after 8-hour fasting

Concentration of C-reactive protein (CRP) in blood serum after 8-hour fasting

Level of Circulating immune complexes (CIC) in blood serum after 8-hour fasting

Concentration of Interleukin-1 (pg/ml) and Interleukin-2 (pg/ml) in blood serum after 8-hour fasting

Concentration of complements (C3, C4) in blood sample after 8-hour fasting

Measurement of central venous pressure (mmh2o) in the central vein

Presence of clinically significant changes on ECG is evaluated.

Presence of clinical signs (adynamia, weakness, memory impairment, sleep disorder, irritability) is based on patient's subjective complaints.

fructose/blutung

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 Peritonitis

Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Burns

Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Sepsis.

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