Evaluation of the Efficacy of Permanent Course Combined Therapy With CYTOFLAVIN® Intravenous Solution and CYTOFLAVIN Tablets, at 2-3 Stages of Rehabilitation of Patients With Post Intensive Care Syndrome

Evaluation of the Efficacy of Permanent Course Combined Therapy With CYTOFLAVIN® Intravenous Solution and CYTOFLAVIN® Tablets, at 2-3 Stages of Rehabilitation of Patients With Post Intensive Care Syndrome

Post intensive care syndrome (PIC syndrome) is an important problem in modern intensive care strategy. Understanding the mechanisms of PIC syndrome helps prevent it in patients with respiratory, neuromuscular transmission, and cognitive impairments that require prolonged support of vital functions. Significant role in the formation and severity of PIC syndrome is played by the severity of the systemic inflammatory response, which is an individual reaction of the body, and this determines the degree of neurological and psychological deficits. Chronic diseases such as diabetes mellitus, especially in the context of metabolic syndrome, worsen the course of PIC syndrome and delays recovery. Early initiation of rehabilitation measures in the intensive care unit and subsequent expansion of the individual rehabilitation program contributes to the rapid and successful recovery of not only vital functions, but also cognitive, motor and emotional disorders. This shortens the hospital stay of patient and improves their quality of life after discharge.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Andrey Belkin, MD; Email: belkin@neuro-ural.ru

Study Locations

• Russian Federation
  • Sverdlovsk region
    • Ekaterinburg, Sverdlovsk region, Russian Federation, 623702
      • Recruiting
      • Brain Institute Clinic
      • Contact: Andrey Belkin, MD; Phone Number: +7 (343) 311-3-380; Email: belkin@neuro-clinic.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The observational program will include adult patients of both sexes with signs of PIC syndrome after a stay in Anesthesiology, reanimation and intensive treatment department due to acute cerebral insufficiency for at least 72 hours, hospitalized for stage 2-3 rehabilitation in a rehabilitation center between 14 and 60 days after the onset of the disease.

The group of patients who received Cytoflavin at stage 1 during the RehabIT program will be "automatically" allocated to the Basic Therapy + Cytoflavin group

Description

Inclusion Criteria:

• Men and women over 18 years of age and older;
• Stay in the ITU and (or) intensive care unit for at least 3 days;
• Diagnosed "post intensive care" syndrome (PIC syndrome) with moderate-to-severe severity >3<6 points
• Diagnosed modalities "critical illness polyneuropathy, respiratory neuropathy, dysphagia" of the domain "Neuromuscular complications" of PIC syndrome at 2-3 stages of the rehabilitation route at any value of PICS severity index
• Diagnosed modalities "decreased gravitational gradient, decreased exercise tolerance" in the domain "Vegetative-metabolic complications" at 2-3 stages of the rehabilitation route at any value of PICS severity index

Exclusion Criteria:

• Premorbid level of vital activity when assessed on the rehabilitation routing scale 4-5 points;
• Hematocrit ≤30%;
• Hemoglobin level ≤80 g/L;
• Acute cardiac failure;
• Acute respiratory failure;
• Acute renal failure;
• Acute liver cell failure;
• Use of drugs from "metabolic agents" pharmacotherapeutic group at the time of inclusion in the study
• Life expectancy of 6 months or less or presence of incurable diseases in decompensation stage

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group 1; Basic therapy + Cytoflavin® intravenous solution in the volume of 20 ml per day IV drip in dilution on 100-200 ml of 5-10% dextrose solution or 0.9% sodium chloride solution during 10 days, transition to Cytoflavin® tablets from the next day after the end of intravenous administration during the next 75 days according to the instructions for medical use
Group 2; Basic therapy, according to clinical guidelines (clinical practice established within the center) for the treatment of patients in stages 2-3 of rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamics of rehabilitation routing status score	Dynamics of rehabilitation routing status score from the start of the study (Visit 1) to Visit 3, Visit 4, Visit 5 and Visit 6 measured in both groups	day 12, day 30, day 60, day 90
Dynamics of Barthel status score	Dynamics of Barthel status score from the start of the study (Visit 1) to Visit 3, Visit 4, Visit 5 and Visit 6 measured in both groups	day 12, day 30, day 60, day 90
Dynamics of EQ5 status score	Dynamics of EQ5 status score from the start of the study (Visit 1) to Visit 3, Visit 4, Visit 5 and Visit 6 measured in both groups	day 12, day 30, day 60, day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamics of somatic status	Dynamics of somatic status from the start of the study (Visit 1) to Visit 3, Visit 4, Visit 5 and Visit 6 measured in both groups	day 12, day 30, day 60, day 90
Dynamics of rehabilitation status	Dynamics of rehabilitation status from the start of the study (Visit 1) to Visit 3, Visit 4, Visit 5 and Visit 6 measured in both groups	day 12, day 30, day 60, day 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification during the event related monitoring of responders and non-responders	Identification during the event related monitoring of responders and non-responders for the use of cytoflavin for adjunctive drug modulation in PIT syndrome rehabilitation	day 12, day 30, day 60, day 90

Collaborators and Investigators

• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Ischemic stroke; Post Intensive Care Unit Syndrome
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: PR-C_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No