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
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Brain Institute Clinic
RECRUITING
Yekaterinburg
Contact Information
Primary
Andrey Belkin, MD
belkin@neuro-ural.ru
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 90
Treatments
Group 1
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
Group 2
Basic therapy, according to clinical guidelines (clinical practice established within the center) for the treatment of patients in stages 2-3 of rehabilitation.
Related Therapeutic Areas
Sponsors
Leads: POLYSAN Scientific & Technological Pharmaceutical Company

This content was sourced from clinicaltrials.gov