Clinical trial NCT06735898: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Keywords: Post Intensive Care Unit Syndrome
Ischemic stroke
Lead sponsor: POLYSAN Scientific & Technological Pharmaceutical Company
Sponsor class: INDUSTRY
First posted: 2024-12-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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 outcomes:
measure: Dynamics of rehabilitation routing status score
timeFrame: day 12, day 30, day 60, day 90
measure: Dynamics of Barthel status score
timeFrame: day 12, day 30, day 60, day 90
measure: Dynamics of EQ5 status score
timeFrame: day 12, day 30, day 60, day 90
Secondary outcomes:
measure: Dynamics of somatic status
timeFrame: day 12, day 30, day 60, day 90
measure: Dynamics of rehabilitation status
timeFrame: day 12, day 30, day 60, day 90
Other outcomes:
measure: Identification during the event related monitoring of responders and non-responders
timeFrame: day 12, day 30, day 60, day 90
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Brain Institute Clinic
state: Sverdlovsk region
Study officials:
References: