An observational study in Ischemic Stroke, sponsored by POLYSAN Scientific & Technological Pharmaceutical Company. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by POLYSAN Scientific & Technological Pharmaceutical Company · Observational
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 90 is below the median of 300 across 771 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →POLYSAN Scientific & Technological Pharmaceutical Company is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Basic therapy, according to clinical guidelines (clinical practice established within the center) for the treatment of patients in stages 2-3 of rehabilitation.
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
Time frame: 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
Time frame: 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
Time frame: day 12, day 30, day 60, day 90
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
Time frame: 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
Time frame: day 12, day 30, day 60, day 90
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
Time frame: day 12, day 30, day 60, day 90
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Dec 2025, 21 months after the start.
Of 42 industry-sponsored observational studies under Ischemic Stroke, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's planned 21 months is below that.
Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.
How these figures are worked out, and which studies are left out of them.
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