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

NCT03764085 | Completed Phase 4

• 1 other identifier: RheoSTAT-CP0620
• Study Type: interventional
• Target: 180
• Locations: 5 countries
• Sites: 13

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

Conditions

Sepsis; Intoxication; Septic

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 (36)

• 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 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 MODS 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.

• 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 sodium

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

Other Outcomes (3)

• Incidence of Treatment-Emergent Adverse events

  Patients will be followed during 14 days.

• Incidence of multiple organ failure

  Patients will be followed during 14 days.

• Overall survival (%) at follow-up visit.

  Follow-up visit (Day 14±1)

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
• 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)
• Informed consent for participation in the study signed by subject's own hand.
• The baseline value of the SOFA scale ≥ 2 points.
• 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)
• Individual intolerance of the 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;
• Lack of data for sepsis (diagnosis not confirmed);
• 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 (13)

"Unimedi Adjara" LLC

Batumi, Georgia

Location

Kutaisi Referral Hospital

Kutaisi, Georgia

Location

Hospital of the Medical Center of the Administration of the President of the Republic of Kazakhstan

Astana, Kazakhstan

Location

Institute of Ambulance

Chisinau, Moldova

Location

Municipal Clinical Hospital "Sfinta Treime"

Chisinau, Moldova

Location

Republican Clinical Hospital

Chisinau, Moldova

Location

Dnipro's Medical Academy of Ministry of Health of Ukraine

Dnipro, 49005, Ukraine

Location

Zaicev's Institute of general and urgent surgery NMA Ukraine

Kharkiv, 61018, Ukraine

Location

Khmelnytskyi Regional Clinical Hospital

Khmelnytskyi, 29000, Ukraine

Location

HSEE of Ukraine "Ukrainian Medical Stomatological Academy"; Poltava Central District Hospital

Poltava, Ukraine

Location

Central District Clinical Hospital

Vinnitsa, 21029, Ukraine

Location

Zaporizka Medical Academy of postgraduate education, Zaporizkyi Clinical Hospital N9

Zaporizhzhya, 69065, Ukraine

Location

Republic Centre of Ambulance

Tashkent, Uzbekistan

Location

MeSH Terms

Conditions

Sepsis; Toxemia

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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 10, 2017
• First Posted: December 4, 2018
• Study Start: December 6, 2016
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-01

Locations

MO (3); GE (2); UZ (1); UA (6); KA (1)