NCT06735898Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 11 Dec 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Diseases
- Stroke
- NCT number
- NCT06735898
What you commit to
- Study type: Observational
- Planned participants: 90
- From 1 Mar 2024 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of drugs from "metabolic agents" pharmacotherapeutic group at the time of inclusion in the study
Other illness
- Acute cardiac failure;
- Acute respiratory failure;
- Acute renal failure;
- Acute liver cell failure;
- Life expectancy of 6 months or less or presence of incurable diseases in decompensation stage
Lab values
- Hemoglobin level ≤80 g/L;
Other
- Premorbid level of vital activity when assessed on the rehabilitation routing scale 4-5 points;
- Hematocrit ≤30%;
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brain Institute Clinic Coordinator of this site? Confirm its status | Yekaterinburg | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.