Patients that receive Cytoflavin® medication i/v drop infusion at a dose of 10 ml of solution for injection per 200 ml of 0.9 % sodium chloride solution for 10 days in addition to a set of neurorehabilitation activities

Patients that subjected to the standard set of neurorehabilitation activities for 10 days without being prescribed Cytoflavin® medication

Ischemic Stroke

Post Intensive Care Unit Syndrome

Brain Institute Clinic

Cytoflavin in the Rehabilitation of Post-intensive Care Syndrome in Stroke Survivors

Use of Cytoflavin Solution at the Time of Early Rehabilitation in Patients With Post-intensive Care Syndrome Who Underwent Ischemic Stroke

Median time (in days) to achieving gravity gradient of 90°.

Proportion of patients who achieved gravity gradient of 90° by day 5 and 10 days of rehabilitation activities

Change in of oxygen consumption during 90° verticalization

Medical Research Council scale for muscle power (MRC), where 0 - tetraplegia, 60 - normal value

Barthel index (BI), when 0 - complete inability to self-service, 100 - full capability of self-service

Modified Rankin scale (MRS), when 0 - no disability, 5 - severe disability

POLYSAN Scientific & Technological Pharmaceutical Company

Patients of group I will receive the experimental drug Cytoflavin®, manufactured by POLYSAN (Russia), on the day before surgery, during the surgical intervention, and in the postoperative period. Cytoflavin® solution(Inosine + Nicotinamide + Riboflavin + Succinic Acid) will be administered IV for 7 days, and Cytoflavin® enteric-coated tablets (Inosine + Nicotinamide + Riboflavin + Succinic Acid) will be administered for 25 days (in total 32 days of treatment).

Patients of group II will receive placebo (manufactured by POLYSAN, Russia), on the day before surgery, during the surgical intervention, and in the postoperative period. Placebo solution will be administered IV for 7 days, and placebo enteric-coated tablets will be administered for 25 days (in total 32 days of treatment).

Cognitive Dysfunction

Single drip infusion of 20 ml of Cytoflavin® solution in 200 ml of 0.9%NaCl intravenously once a day

Cytoflavin® solution

2 tablets, orally, with 100 ml of drinking water, 30 minutes before meals, 2 times a day, with an interval of 8-10 hours (but no later than 18:00).

Cytoflavin® enteric-coated tablet

Single drip infusion of 20 ml of placebo solution in 200 ml of 0.9%NaCl intravenously once a day

Placebo solution

Placebo enteric-coated tablet

Regional Clinical Hospital № 3

Central Clinical Hospital with a polyclinic of the Office of the President of the Russian Federation

Alexandrovskaya City Hospital

City Hospital №15

City Hospital №38 named after N.A. Semashko

City Hospital №40 of the Kurortny District

Hospital for War Veterans

I. P. Pavlov 1st St. Petersburg State Medical University

Military Medical Academy named after S.M. Kirov

Pokrovskaya City Hospital

GBUZ YAO "Regional Clinical Hospital"

Research center of specialized types of medical care "Ural Institute of Cardiology"

Ural State Medical University

Efficacy and Safety of Cytoflavin® Used in Elderly Patients for the Prevention of Cognitive Decline After Major Surgery

A Multicentre Double-blind Placebo-controlled Randomized Study of Efficacy and Safety of Cytoflavin®, Intravenous Administration and Enteric-coated Tablets, Used in Elderly Patients for Prevention of Cognitive Decline After Major Surgery

The MoCA test is a one-page 30-point test, ranging between 0 and 30, where 0 is the worst and 30 is the best result; a score of 26-30 or over is considered to be normal. Outcome measure is the change in the MoCA scale score by the end of the treatment course compared with the preoperative score.

MMSE test is a 30-point questionnaire; any score greater than or equal to 24 points (out of 30) indicates a normal cognition; below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. Outcome measure will be the change of MMSE scale score by the end of the treatment course compared to the preoperative score

MMSE test is a 30-point questionnaire; any score greater than or equal to 24 points (out of 30) indicates a normal cognition; below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. Outcome measure will be the change of MMSE scale score by the end of the follow-up period

The MoCA test is a one-page 30-point test, ranging between 0 and 30, where 0 is the worst and 30 is the best result; a score of 26-30 or over is considered to be normal. Outcome measure is the change of the MoCA scale score by the end of the follow-up period

MMSE test is a 30-point questionnaire; any score greater than or equal to 24 points (out of 30) indicates a normal cognition; below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. Outcome measure will be the difference between median group total scores on the MMSE scale.

The MoCA test is a one-page 30-point test, ranging between 0 and 30, where 0 is the worst and 30 is the best result; a score of 26-30 or over is considered to be normal. Outcome measure is the difference in median group values of the MOCA scale

The proportion of patients who developed postoperative delirium in the first 96 hours after surgery according to the results of CAM-ICU

Mortality in the postoperative period in the experimental and control groups

The proportion of patients with a decrease in the results of two or more neuropsychological tests by more than 20% by the end of the treatment course and by the end of the follow-up period compared the baseline values

Change in the overall score for the EQ-5D questionnaire for assessing the quality of life

The proportion of patients dependent in at least two daily functions according to the results of the Katz Daily Activity Index at the end of the treatment course

The group average score by Hospital Anxiety and Depression Scale (HADS) at the end of the treatment course and at the end of the follow-up period. The HADS is a fourteen item scale, a person can score between 0 and 21 for either anxiety or depression, where scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21).

succinic acid/mŕtvica

Cytoflavin in the Rehabilitation of Post-intensive Care Syndrome in Stroke Survivors

Efficacy and Safety of Cytoflavin® Used in Elderly Patients for the Prevention of Cognitive Decline After Major Surgery

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