PeritonitisPhase 4NCT03771170
Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Peritonitis
A Phase 4 study testing Rheosorbilact® and Ringer lactate in people with Peritonitis and Intoxication, run by Yuria-Pharm at 10 sites in 4 countries.
Trial 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 peritonitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Peritonitis, Intoxication
- What is being tested?
- Rheosorbilact® and Ringer lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 10 Jan 2018to 3 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female aged 18 to 60 years inclusive
- Purulent peritonitis in two or more anatomical parts of the abdominal cavity diagnosed according to Mannheim Peritonitis Index (MPI) Score from 21 to 29 (no later than 24 hours after primary laparotomy and revision of the abdominal cavity).
- Informed consent for participation in the study signed by subject's own hand.
- The baseline value of the SOFA scale ≥ 2 points.
- Non-inclusion Criteria:
- The presence of any of the criteria for severe sepsis by ACCP / SCCM;
Show all 26Show fewer
- The MPI index is less than 21 or more than 29 points;
- Individual intolerance of the components of the study drug and the reference drug
- Hypersensitivity to sodium lactate
- Pregnancy or breast-feeding
- Intravenous infusions of lactate- or sorbitol-containing products within 24 hours before enrollment;
- Severe renal dysfunction (creatinine is more than 300 μmol/l or estimated creatinine clearance is less than 30 ml/min);
- Metabolic alkalosis;
- Severe metabolic acidosis;
- Intracerebral hemorrhage;
- Any thromboembolism;
- Decompensated cardiovascular failure;
- Arterial hypertension III st;
- Conditions associated with immunodeficiency (the use of cytostatics or system steroids, AIDS);
- Extracellular hyperhydration or hypervolemia;
- Severe renal insuffiency (with oliguria / anuria);
- Hyperkalaemia;
- Hypercalcemia;
- Ascites associated with cirrhosis;
- Conditions associated with increased lactate levels (hyperlactatemia > 2 mmol / l), including lactic acidosis, or impaired lactate uptake (including due severe hepatic insufficiency);
- Concomitant therapy with cardiac glycosides;
Who cannot join
- Infusion of the study drug or the comparator is started more than 12 hours after randomization;
- Lack of data for peritonities (diagnosis not confirmed);
- Withdrawal of the informed consent by the subject;
- Investigator considers that the infusion therapy with either study drug or comparator may not be continued for safety reasons;
- Development of conditions that prevent further use of the study drug/comparator before efficacy evaluation visit (Visit 3);
- Subject needs concomitant therapy prohibited in the study before efficacy evaluation visit (Visit 3);
- Development of conditions (including serious adverse events) which make it impossible to evaluate the primary endpoint;
- Confirmation of pregnancy at any time of the study.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Georgia3 sites
"Unimedi Adjara" LLC
Batumi
Kutaisi Referral Hospital
Kutaisi
JSC EVEX/LTD Traumatology
Tbilisi
Moldova3 sites
Institute of Ambulance
Chisinau
Municipal Clinical Hospital
Chisinau
Republican Clinical Hospital
Chisinau
Ukraine3 sites
Institute of General and Urgent Surgery of the National Academy of Medical Sciences of Ukraine
Kharkiv
Kyiv City Clinical Hospital No.4; National Medical University named after O.O. Bogomolets
Kyiv
HSEE of Ukraine "Ukrainian Medical Stomatological Academy"; Poltava Central District Hospital
Poltava
About this study
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 Peritonitis.
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 peritonitis. Half of participants will receive Rheosorbilact® in complex therapy, while the other half will receive Ringer's Lactate in complex therapy.
Read the 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.
- Conditions
- Peritonitis, Intoxication
- Being tested
- Rheosorbilact®, Ringer lactate
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rheosorbilact®Drug
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.
Ringer lactateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Rheosorbilact® | Experimental | 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. Receives: Drug: Rheosorbilact® |
| Ringer lactate | Active comparator | 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. Receives: Drug: Ringer lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in the total SOFA score vs. baseline score upon admission;
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).
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Secondary outcomes (40)
A change in the total APACHE II score vs. baseline score upon admission;
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).
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
A change in the total SAPS II score vs. baseline score upon admission
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).
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
A change in the total MODS score vs. baseline score upon admission
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).
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
A change in the total MPI score vs. baseline score upon admission
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).
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of glucose
Concentration of glucose (mmol/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of sodium
Concentration of sodium (mmol/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of potassium
Concentration of potassium (mmol/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of lactate.
Concentration of lactate (mmol/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of pyruvate.
Concentration of pyruvate (mmol/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of urea.
Concentration of urea (mmol/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of creatinine.
Concentration of creatinine (µmol/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of bilirubin.
Concentration of bilirubin (µmol/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of alanine aminotransferase.
Concentration of alanine aminotransferase (U/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of aspartate aminotransferase.
Concentration of aspartate aminotransferase (U/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of lactate dehydrogenase.
Concentration of lactate dehydrogenase (U/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of alkaline phosphatase.
Concentration of alkaline phosphatase (U/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of creatine kinase.
Concentration of creatine kinase (U/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of γ-Glutamyltransferase
Concentration of γ-Glutamyltransferase (U/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of low-molecular-weight adiponectin (LMW)
Concentration of low-molecular-weight adiponectin (U/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of middle-molecular-weight adiponectin (MMW)
Concentration of middle-molecular-weight adiponectin (U/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of albumin.
Concentration of albumin in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Procalcitonin level.
Concentration of procalcitonin level (µg/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
White blood cells (WBC) count level.
White blood cells (billion/L) count level in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Lymphocyte count level.
Lymphocyte count (%) level in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Platelet count level.
Platelet count level (billion/L) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Calculation of Nuclear index of intoxication (NII)
Calculated by dividing the number of myelocytes, young and stab neutrophils by number of segmented neutrophils.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Calculation of Leukocyte index of intoxication (LII).
Calculated by the formula of Kalf-Kalifa: correlation between the level of neutrophils and the content of other cells in the blood leukocytic composition.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of C-reactive protein (CRP).
Concentration of C-reactive protein (CRP) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Level of circulating immune complexes (CIC).
Level of Circulating immune complexes (CIC) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of Interleukin-1 and 2.
Concentration of Interleukin-1 (pg/ml) and Interleukin-2 (pg/ml) in blood serum after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Calculation of neutrophil-to-lymphocyte ratio (NLR).
Calculated by dividing the number of neutrophils (%) by number of lymphocytes (%).
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of immunoglobulins
Concentration of Ig A, Ig M and Ig G in blood serum after 8-hour fasting
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of complements.
Concentration of complements (C3, C4) in blood sample after 8-hour fasting.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Assessment of central hemodynamics.
Measurement of central venous pressure (mmh2o) in the central vein.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
A change in the total Glasgow Coma Scale (GCS) score vs. baseline score upon admission
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).
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Measurement of 12-lead electrocardiogram (ECG)
Measurement of 12-lead ECG with further evaluation and interpretation whether the ECG waves, intervals, durations and rhythm are normal.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Number of participants with Presence of clinical signs
Number of participants with presence of clinical signs such as adynamia, weakness, memory impairment, sleep disorder, irritability, evaluated according to patient's subjective complaints.
Measured: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Incidence of Treatment-Emergent Adverse events.
All types of adverse events.
Measured: Patients will be followed during 14 days.
Incidence of multiple organ failure
Incidence of multiple organ failure
Measured: Patients will be followed during 14 days.
Overall survival (%) at follow-up visit.
Overall survival (%) at follow-up visit.
Measured: Follow-up visit (Day 14±1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start10 Jan 2018
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuria-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771170
- Sponsor's protocol ID
- RheoSTAT-CP0691
- Status last verified
- Jan 2020
- First submitted
- 5 Dec 2018
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Peritonitis.
- ClinicalTrials.gov ID
- NCT03771170
- Acronym / sponsor ID
- RheoSTAT-CP0691
- Conditions
- Peritonitis, Intoxication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Yuria-PharmIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 peritonitis. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Rheosorbilact® | Experimental | Drug: Rheosorbilact®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 lactate | Active comparator | Drug: Ringer lactateRinger'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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- Male and female aged 18 to 60 years inclusive
- Purulent peritonitis in two or more anatomical parts of the abdominal cavity diagnosed according to Mannheim Peritonitis Index (MPI) Score from 21 to 29 (no later than 24 hours after primary laparotomy and revision of the abdominal cavity).
- Informed consent for participation in the study signed by subject's own hand.
- The baseline value of the SOFA scale ≥ 2 points.
- The presence of any of the criteria for severe sepsis by ACCP / SCCM;
Key exclusion criteria (8 listed)
- Infusion of the study drug or the comparator is started more than 12 hours after randomization;
- Lack of data for peritonities (diagnosis not confirmed);
- Withdrawal of the informed consent by the subject;
- Investigator considers that the infusion therapy with either study drug or comparator may not be continued for safety reasons;
- Development of conditions that prevent further use of the study drug/comparator before efficacy evaluation visit (Visit 3);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rheosorbilact®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. | Drug | Rheosorbilact® |
| Ringer lactateAdministered 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. | Drug | Ringer lactate |
Primary outcome
A change in the total SOFA score vs. baseline score upon admission;
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
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).
40 secondary outcomes
A change in the total APACHE II score vs. baseline score upon admission;
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
A change in the total SAPS II score vs. baseline score upon admission
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
A change in the total MODS score vs. baseline score upon admission
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
A change in the total MPI score vs. baseline score upon admission
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of glucose
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of sodium
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of potassium
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of lactate.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of pyruvate.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of urea.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of creatinine.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of bilirubin.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of alanine aminotransferase.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of aspartate aminotransferase.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of lactate dehydrogenase.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of alkaline phosphatase.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of creatine kinase.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of γ-Glutamyltransferase
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of low-molecular-weight adiponectin (LMW)
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of middle-molecular-weight adiponectin (MMW)
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of albumin.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Procalcitonin level.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
White blood cells (WBC) count level.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Lymphocyte count level.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Platelet count level.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Calculation of Nuclear index of intoxication (NII)
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Calculation of Leukocyte index of intoxication (LII).
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of C-reactive protein (CRP).
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Level of circulating immune complexes (CIC).
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of Interleukin-1 and 2.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Calculation of neutrophil-to-lymphocyte ratio (NLR).
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of immunoglobulins
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Concentration of complements.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Assessment of central hemodynamics.
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
A change in the total Glasgow Coma Scale (GCS) score vs. baseline score upon admission
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Measurement of 12-lead electrocardiogram (ECG)
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Number of participants with Presence of clinical signs
Time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.
Incidence of Treatment-Emergent Adverse events.
Time frame: Patients will be followed during 14 days.
Incidence of multiple organ failure
Time frame: Patients will be followed during 14 days.
Overall survival (%) at follow-up visit.
Time frame: Follow-up visit (Day 14±1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rheosorbilact® and Ringer lactate in people with Peritonitis and Intoxication, run by Yuria-Pharm at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Georgia, Moldova, Ukraine, Uzbekistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change in the total SOFA score vs. baseline score upon admission; (time frame: Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.