Status:
COMPLETED
Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Pneumonia
Lead Sponsor:
Yuria-Pharm
Conditions:
Pneumonia
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 pneumonia...
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 conv...
Eligibility Criteria
Inclusion
- Men and women aged 18 to 45 years inclusive;
- Community-acquired pneumonia with a prescription from the beginning of antibacterial therapy no more than 48 hours;
- The risk class of pneumonia in the PSI/PORT index score is at least IV;
- 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:
- Individual intolerance of the components of the study drug and reference preparation;
- Hypersensitivity to sodium lactate;
- 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);
- Pregnancy or breast-feeding;
- 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, diabetes mellitus);
- Extracellular hyperhydration or hypervolemia;
- Severe renal insuffiency (with oliguria/anuria);
- Hyperkalemia;
- 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.
Exclusion
- Infusion of the study drug or the comparator is started more than 12 hours after randomization;
- Lack of data for community-acquired pneumonia (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.
Key Trial Info
Start Date :
January 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03824457
Start Date
January 8 2018
End Date
February 17 2020
Last Update
February 18 2020
Active Locations (12)
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1
"Unimedi Adjara" LLC
Batumi, Georgia
2
JSC EVEX Medical corporation/Kutaisi Referral Hospital
Kutaisi, Georgia
3
"Israel Georgian Medical Research Clinic HELSI Core LLC" LTD.
Tbilisi, Georgia
4
Hospital of the Medical Center Office of the President's Affairs Republic of Kazakhstan
Astana, Kazakhstan