Status:
COMPLETED
Efficacy and Safety of Rheosorbilact® Solution for Infusion, in a Complex Therapy of Sepsis.
Lead Sponsor:
Yuria-Pharm
Conditions:
Sepsis
Intoxication; Septic
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 sepsis. H...
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
- Male and female aged 18 to 60 years inclusive
- Sepsis diagnosed according to ACCP / SCCM criteria (no later than 24 hours from the time of diagnosis of sepsis to screening visit) (Annex 1: Sequence Diagnostic Criteria for SCCM / ESICM / ACCP / ATS / SIS)
- 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 (presence of signs of organ failure - Annex 1: criteria for diagnosis of sepsis SCCM / ESICM / ACCP / ATS / SIS)
- Individual intolerance of the components of the study drug and the comparator;
- Hypersensitivity to sodium lactate;
- Intravenous infusions of lactate- or sorbitol-containing products within 24 hours before enrollment;
- Pregnancy or breast-feeding;
- 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;
Exclusion
- Infusion of the study drug or the comparator is started more than 12 hours after randomization;
- Lack of data for sepsis (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 :
December 6 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2019
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03764085
Start Date
December 6 2016
End Date
December 11 2019
Last Update
February 21 2020
Active Locations (13)
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1
"Unimedi Adjara" LLC
Batumi, Georgia
2
Kutaisi Referral Hospital
Kutaisi, Georgia
3
Hospital of the Medical Center of the Administration of the President of the Republic of Kazakhstan
Astana, Kazakhstan
4
Institute of Ambulance
Chisinau, Moldova