Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 converted into fructose, which is then converted into glucose, and then into glycogen. Part of sorbitol is used for urgent energy needs, while the other part is kept as a reserve in the form of glycogen. Isotonic sorbitol solution has a disaggregating effect and, therefore, improves microcirculation and tissue perfusion.

The management of metabolic acidosis with sodium lactate goes more slowly compared to bicarbonate solution, as far as sodium lactate enters the metabolic process; however the latter does not cause swings in pH values. The effect of sodium lactate is typically seen 20 to 30 minutes after administration.

Sodium chloride is a plasma-substituting agent that exhibits a detoxification and rehydration effect. It replenishes the deficiency of sodium and chlorine ions in various pathological conditions.

Calcium chloride replenishes deficiency of calcium ions. Calcium ions are essential in the transmission of nerve impulses, contraction of skeletal and smooth muscles, myocardial activity, bone tissue formation, and blood clotting. It reduces the permeability of cells and vascular walls, prevents the development of inflammatory reactions, enhances the resistance of the body to infections and can significantly boost phagocytosis.

Potassium chloride restores the water-electrolyte balance. It exhibits a negative chrono- and bathmotropic action and, when administered in high doses, has a negative ino- and dromotropic and moderate diuretic effect. It is involved in the process of nerve impulse conduction, increases the content of acetylcholine and causes excitation of the sympathetic segment of the autonomic nervous system and improves the contraction of skeletal muscles in subjects with muscular dystrophy or myasthenia.

Rheosorbilact® is administered to improve capillary blood flow for the prevention and treatment of traumatic, surgical, hemolytic, toxic and burn shock, acute blood loss, and burn disease; infectious diseases accompanied by intoxication, exacerbation of chronic hepatitis; sepsis, pre- and postoperative period to improve arterial and venous circulation for the prevention and treatment of thrombosis, thrombophlebitis, endarteritis, and Raynaud's disease.

Ringer's Lactate, solution for infusion will be used as a comparator. As a rehydrating agent, Ringer's Lactate has a detoxification effect, replenishes the deficiency of circulating blood volume, and stabilizes the water and electrolyte composition of blood. Ringer's Lactate normalizes the acid-base balance. Lactate is metabolized in the body to bicarbonate, so the solution has an alkalizing effect. With osmolarity at 273 mOsm/l, Ringer's Lactate is close to isotonic solution and is indicated for hypovolemia, isotonic dehydration, and metabolic alkalosis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03771170
Study type Interventional
Source Yuria-Pharm
Contact
Status Completed
Phase Phase 4
Start date January 10, 2018
Completion date December 3, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT04070196 - Point-of-care Test for Diagnosis of Peritonitis in Peritoneal Dialysis Patients N/A
Completed NCT00657566 - SIS Multicenter Study of Duration of Antibiotics for Intraabdominal Infection Phase 3
Recruiting NCT00131196 - Functional Genomic Influences on Disease Progression and Outcome in Sepsis N/A
Completed NCT00195351 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Phase 4
Completed NCT04182217 - Descriptive and Correlational Study of Peritonitis in Haiti.
Recruiting NCT03310606 - Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis N/A
Completed NCT01222663 - Effects of Hemoperfusion With a Polymyxin B Membrane in Peritonitis With Septic Shock Phase 3
Completed NCT00230971 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Phase 4
Recruiting NCT03790176 - ZAVI APD ELF Protocol v2.2 Phase 1
Completed NCT03668197 - Children Peritonitis Ecology at CHU de Rennes - (IIAPEDIA)
Recruiting NCT01837342 - Multicenter Study Comparing Morbidity and Quality of Life Associated in the Treatment by Surgical Resection and the Conservative Treatment, After Favorable Evolution of Purulent Peritonitis That Originates From Diverticulitis Treated by Mini-invasive Surgery N/A
Completed NCT00497744 - A Pharmacokinetic Study of Cefepime After Administration Into Dialysate in Patients With Continuous Ambulatory Peritoneal Dialysis (CAPD) Peritonitis N/A
Recruiting NCT03334006 - Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis (the PEPPER Trial). Phase 2
Terminated NCT03403751 - Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury Phase 3
Withdrawn NCT00463762 - Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections. Phase 4
Active, not recruiting NCT02755610 - Check List to Improve Patient Self-care and Product Defect Report in Continuous Ambulatory Peritoneal Dialysis N/A
Not yet recruiting NCT05308849 - Peritoneal Diffusion and Efficacy of Antibiotic Therapy in Pediatric Peritonitis N/A
Completed NCT02726932 - Intra-abdominal View and Inflammatory Markers in Secondary Peritonitis - Correlation to Recovery
Recruiting NCT05050253 - Lavage With Super-Oxidized Solution for Secondary Peritonitis N/A
Completed NCT02926846 - IV Antibiotics With Lavage for Severe PD Peritonitis Phase 4