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

• Status: Completed
• Trial end date: 2019-12-03
• 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 peritonitis. 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. 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).

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;

2. The MPI index is less than 21 or more than 29 points;

3. Individual intolerance of the components of the study drug and the reference drug

4. Hypersensitivity to sodium lactate

5. Pregnancy or breast-feeding

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

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

8. Metabolic alkalosis;

9. Severe metabolic acidosis;

10. Intracerebral hemorrhage;

11. Any thromboembolism;

12. Decompensated cardiovascular failure;

13. Arterial hypertension III st;

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

15. Extracellular hyperhydration or hypervolemia;

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

17. Hyperkalaemia;

18. Hypercalcemia;

19. Ascites associated with cirrhosis;

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

21. 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 peritonities (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.