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

NCT04152096 | Completed Phase 4

• 1 other identifier: RheoSTAT-CP0669
• Study Type: interventional
• Target: 118
• Locations: 4 countries
• Sites: 5

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

Conditions

Burns; Intoxication

Outcome Measures

Primary Outcomes (1)

• A change in the total SOFA score vs. baseline score upon admission

  Sequential Organ Failure Assessment (SOFA) score is composed of scores of six organ systems: R-respiratory, C-cardiovascular, H-hepatic, Co-coagulation, Re-renal, and N-neurological graded from 0 to 4 according to the degree of dysfunction or failure. The SOFA score ranges from 0 to 24 points. We evaluate initial SOFA score and differences between subsequent scores (Δ-SOFA scores).

  Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.

Secondary Outcomes (37)

• A change in the total APACHE II score vs. baseline score upon admission

  Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.

• A change in the total SAPS II score on day 3 vs. baseline score upon admission

  Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.

• A change in the total Spronk score on day 3 vs. baseline score upon admission

  Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.

• Concentration of glucose

  Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.

• Concentration of lactate.

  Will be evaluated for the duration of Intensive Care Unit (ICU) stay, at screening (Day 0) and Visit 3 (Day 3) of ICU stay.

Study Arms (2)

Rheosorbilact®

EXPERIMENTAL

Rheosorbilact® is administered as a part of the infusion therapy intravenously (with speed 40-60 drip per minute) at a dose of 600 to 1,000 ml (10 to 15 ml/kg body weight per 24 hours).The period of the treatment with the study drug lasts 3 days.

Drug: Rheosorbilact®

Ringer's Lactate

ACTIVE COMPARATOR

Ringer's Lactate is administered as a part of the infusion therapy intravenously (with speed 40-60 drip per minute) at a dose of 1,000 to 2,500 ml (15 to 40 ml/kg body weight per 24 hours).The period of the treatment with the active comparator lasts 3 days.

Drug: Ringer lactate

Interventions

Rheosorbilact® DRUG

Administered intravenously (with speed 40-60 drip per minute) at a dose of 600 to 1,000 ml (10 to 15 ml/kg body weight per 24 hours) for 3 days.

Rheosorbilact®

Ringer lactate DRUG

Administered intravenously (with speed 40-60 drip per minute) at a dose of 1,000 to 2,500 ml (15 to 40 ml/kg body weight per 24 hours) for 3 days.

Ringer's Lactate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female aged 18 to 60 years inclusive
• 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.
• Severity of state according to the Frank index from 30 to 90.
• The duration of the resulting thermal injury no more than 3 days from the planned first administration of the drug
• Informed consent for participation in the study signed by subject's own hand.
• Individual intolerance to 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;

You may not qualify if:

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

Sponsors & Collaborators

• Yuria-Pharm: lead

Study Sites (5)

Karaganda State Medical University; Regional Center of Traumatology and Orthopedics named after Professor H.Zh.Makazhanov

Karaganda, Kazakhstan

Location

Republic Clinical Hospital of Traumatology and Orthopedy

Chisinau, Moldova

Location

Kyiv City Clinical Hospital №2; Shupyk National Medical Academy of Postgraduate Education

Kyiv, Ukraine

Location

Vinnytska Pyrohov's State Clinical Hospital

Vinnytsia, Ukraine

Location

Republic Scientific Center of Ambulance

Tashkent, Uzbekistan

Location

MeSH Terms

Conditions

Burns

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor will perform the assessment of primary, secondary efficasy and safety parameters
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 5, 2019
• Study Start: February 2, 2017
• Primary Completion: September 30, 2020
• Study Completion: May 12, 2021
• Last Updated: March 10, 2025

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1); UZ (1); KA (1); UA (2)