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

Recruiting

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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Dynamics of rehabilitation routing status score	day 12, day 30, day 60, day 90	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
Dynamics of Barthel status score	day 12, day 30, day 60, day 90	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
Dynamics of EQ5 status score	day 12, day 30, day 60, day 90	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

Secondary Outcome Measures

Name	Time	Method
Dynamics of somatic status	day 12, day 30, day 60, day 90	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
Dynamics of rehabilitation status	day 12, day 30, day 60, day 90	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

Locations (1): Brain Institute Clinic
🇷🇺
Ekaterinburg, Sverdlovsk region, Russian Federation

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