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

• Status: Completed
• Trial end date: 2019-12-11
• Target enrollment: 0
• Participant gender: All

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. Half of participants will receive Rheosorbilact® in complex therapy, while the other half will receive Ringer's Lactate in complex therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuria-Pharm

Criteria

Inclusion Criteria:

1. Male and female aged 18 to 60 years inclusive

2. 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)

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

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

Non-inclusion Criteria:

1. 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)

2. Individual intolerance of the components of the study drug and the comparator;

3. Hypersensitivity to sodium lactate;

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

5. Pregnancy or breast-feeding;

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

7. Metabolic alkalosis;

8. Severe metabolic acidosis;

9. Intracerebral hemorrhage;

10. Any thromboembolism;

11. Decompensated cardiovascular failure;

12. Arterial hypertension III st;

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

14. Extracellular hyperhydration or hypervolemia;

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

16. Hyperkalaemia;

17. Hypercalcemia;

18. Ascites associated with cirrhosis;

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

20. 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 sepsis (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.