Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06735898
Enrollment
90
Registered
2024-12-16
Start date
2024-03-01
Completion date
2026-05-01
Last updated
2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Post Intensive Care Unit Syndrome, Ischemic stroke

Brief summary

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.

Interventions

None listed

Sponsors

POLYSAN Scientific & Technological Pharmaceutical Company
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dynamics of rehabilitation routing status scoreday 12, day 30, day 60, day 90Dynamics 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
Dynamics of Barthel status scoreday 12, day 30, day 60, day 90Dynamics 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
Dynamics of EQ5 status scoreday 12, day 30, day 60, day 90Dynamics 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

Secondary

MeasureTime frameDescription
Dynamics of somatic statusday 12, day 30, day 60, day 90Dynamics 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
Dynamics of rehabilitation statusday 12, day 30, day 60, day 90Dynamics 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

Other

MeasureTime frameDescription
Identification during the event related monitoring of responders and non-respondersday 12, day 30, day 60, day 90Identification during the event related monitoring of responders and non-responders for the use of cytoflavin for adjunctive drug modulation in PIT syndrome rehabilitation

Countries

Russia

Contacts

Primary ContactAndrey Belkin, MD
belkin@neuro-ural.ru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026