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NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brain Institute Clinic

Yekaterinburg, Sverdlovsk Oblast, 623702, Russia

Location status: Recruiting

Location contact

Andrey Belkin, MD

CONTACT

[email protected]

+7 (343) 311-3-380

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dynamics of rehabilitation routing status score

    Time frame: day 12, day 30, day 60, day 90

    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

  2. Dynamics of Barthel status score

    Time frame: day 12, day 30, day 60, day 90

    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

  3. Dynamics of EQ5 status score

    Time frame: day 12, day 30, day 60, day 90

    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

Secondary outcomes

  1. Dynamics of somatic status

    Time frame: day 12, day 30, day 60, day 90

    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

  2. Dynamics of rehabilitation status

    Time frame: day 12, day 30, day 60, day 90

    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

Other outcomes

  1. Identification during the event related monitoring of responders and non-responders

    Time frame: day 12, day 30, day 60, day 90

    Identification during the event related monitoring of responders and non-responders for the use of cytoflavin for adjunctive drug modulation in PIT syndrome rehabilitation

Study contacts

Contact information is provided by the study sponsor or research team.

Andrey Belkin, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

POLYSAN Scientific & Technological Pharmaceutical Company

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 16, 2024
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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