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

• Status: Unknown status
• Trial end date: 2021-03-30
• 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 burns. 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
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Male and female aged 18 to 60 years inclusive

2. Thermal damage of 2nd stage with a total area of at least 20% and not more than 45% of the body surface.It is acceptable to include patients with deep burns, with a total area from 3% to 15% of the body surface in combination with superficial burns or isolated.

3. Severity of state according to the Frank index from 30 to 90.

4. The duration of the resulting thermal injury no more than 3 days from the planned first administration of the drug

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

Non-inclusion Criteria:

1. Individual intolerance to components of the study drug and the comparator;

2. Hypersensitivity to sodium lactate;

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

4. Pregnancy or breast-feeding;

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

6. Metabolic alkalosis;

7. Severe metabolic acidosis;

8. Intracerebral hemorrhage;

9. Any thromboembolism;

10. Decompensated cardiovascular failure;

11. Blood hypertension, grade III (SBP ≥ 180 mm Hg and/or DBP ≥ 90 mm Hg);

12. Conditions associated with immunodeficiency (use of cytotoxic drugs or systemic steroids, AIDS, diabetes mellitus);

13. Extracellular hyperhydration or hypervolemia;

14. Severe renal insufficiency (with oliguria/anuria);

15. Hyperkalemia;

16. Hypercalcemia;

17. Ascites associated with cirrhosis;

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

19. Concomitant therapy with cardiac glycosides.

20. The need for artificial ventilation

21. The presence of HIV or other immunodeficiency conditions

22. Diabetes mellitus type I or type II with the need for insulin;

23. The need for hemodialysis or other methods of extracorporeal detoxification

24. Conducting chemotherapy now or within 60 days before enrollment

25. Continuous use of corticosteroids in any form in a dose exceeding the equivalent of 10 mg of prednisolone per day

26. The total burn area is less than 20% or more than 45% of the body surface

27. The presence of deep burns (3 degrees and higher in the ICD-10).

28. Localization of burns in areas that interfere with the infusion of the test drug.

29. The severity of the state according to the Frank index is less than 30 and more than 90 units

Exclusion Criteria:

1. Infusion of the study drug or the comparator is started more than 12 hours after randomization;

2. Withdrawal of the informed consent by the subject;

3. Investigator considers that the infusion therapy with either study drug or comparator may not be continued for safety reasons;

4. Development of conditions that prevent further use of the study drug/comparator before efficacy evaluation visit (Visit 3);

5. Subject needs concomitant therapy prohibited in the study before efficacy evaluation visit (Visit 3);

6. Development of conditions (including serious adverse events) which make it impossible to evaluate the primary endpoint;

7. Confirmation of pregnancy at any time of the study.