Evaluating a combined therapy for patients recovering from post intensive care syndrome after ischemic stroke

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

This study is testing a new combined therapy to help people recovering from post intensive care syndrome after an ischemic stroke feel better during their rehabilitation.

Quick facts

• Study type: Observational
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company (Industry-sponsored)
• Locations: 1 site (Yekaterinburg, Sverdlovsk Oblast)
• Trial ID: NCT06735898 on ClinicalTrials.gov

What this trial studies

This study focuses on patients who have experienced post intensive care syndrome (PIC syndrome) following an ischemic stroke. It aims to evaluate the efficacy of a combined therapy using CYTOFLAVIN® intravenous solution and tablets during the rehabilitation process. The approach emphasizes early rehabilitation interventions to address cognitive, motor, and emotional disorders that arise from prolonged intensive care. The study will include patients who have been in intensive care for at least three days and have moderate-to-severe PIC syndrome.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who have been in intensive care for at least three days and have a diagnosis of moderate-to-severe post intensive care syndrome.

Not a fit: Patients with acute organ failures or those with a premorbid level of vital activity assessed as 4-5 points may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve recovery outcomes for patients suffering from post intensive care syndrome.

How similar studies have performed: While the specific combination therapy is novel, similar rehabilitation approaches have shown promise in improving outcomes for patients with post intensive care syndrome.

Eligibility criteria

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

Where this trial is running

Yekaterinburg, Sverdlovsk Oblast

• Brain Institute Clinic — Yekaterinburg, Sverdlovsk Oblast, Russia (Recruiting)

Study contacts

• Study coordinator: Andrey Belkin, MD

Conditions Ischemic Stroke; Post Intensive Care Unit Syndrome; Ischemic stroke