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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial 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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 2 trial groups
Group A: Group 1
Group B: Group 2

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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

Other outcomes

1

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

Sponsors and contacts

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