NCT03771170

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2018

Geographic Reach
4 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2019

Completed
Last Updated

February 21, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

December 5, 2018

Last Update Submit

February 20, 2020

Conditions

PeritonitisIntoxication

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 (40)

  • 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.

  • A change in the total MPI 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.

  • +35 more secondary outcomes

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 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 lactateDRUG

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 lactate

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female aged 18 to 60 years inclusive
  • 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).
  • 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;
  • The MPI index is less than 21 or more than 29 points;
  • Individual intolerance of the components of the study drug and the reference drug
  • Hypersensitivity to sodium lactate
  • Pregnancy or breast-feeding
  • Intravenous infusions of lactate- or sorbitol-containing products within 24 hours before enrollment;
  • 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;
  • +10 more criteria

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 peritonities (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

"Unimedi Adjara" LLC

Batumi, Georgia

Location

Kutaisi Referral Hospital

Kutaisi, Georgia

Location

JSC EVEX/LTD Traumatology

Tbilisi, Georgia

Location

Institute of Ambulance

Chisinau, Moldova

Location

Municipal Clinical Hospital

Chisinau, Moldova

Location

Republican Clinical Hospital

Chisinau, Moldova

Location

Institute of General and Urgent Surgery of the National Academy of Medical Sciences of Ukraine

Kharkiv, Ukraine

Location

Kyiv City Clinical Hospital No.4; National Medical University named after O.O. Bogomolets

Kyiv, Ukraine

Location

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

Poltava, Ukraine

Location

Republic Centre of Ambulance

Tashkent, Uzbekistan

Location

MeSH Terms

Conditions

Peritonitis

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical 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
Model Details: Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 11, 2018

Study Start

January 10, 2018

Primary Completion

December 3, 2019

Study Completion

December 3, 2019

Last Updated

February 21, 2020

Record last verified: 2020-01

Locations

MO(3)UA(3)GE(3)UZ(1)