Cytoflavin in the Rehabilitation of Post-intensive Care Syndrome in Stroke Survivors

NCT04194229 | Completed

• 1 other identifier: PR-C
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Objective - to assess the effect of Cytoflavin® and its tolerability within the integrated program of rehabilitation of patients who underwent ischemic stroke

Conditions

Ischemic Stroke; Post Intensive Care Unit Syndrome

Keywords

Ischemic stroke; Post-intensive care syndrome; Cytoflavin; Rehabilitation; Metabolograph; Utilization O2; Verticalization

Outcome Measures

Primary Outcomes (1)

• Median time to achieving gravity gradient of 90°

  Median time (in days) to achieving gravity gradient of 90°.

  10 days

Secondary Outcomes (5)

• Proportion of patients who achieved gravity gradient of 90°

  5 and 10 days

• Change in of oxygen consumption during 90° verticalization

  5 and 10 days

• Change in the Medical Research Council (MRC) scale for muscle strength score

  5 and 10 days

• Change in Barthel index (BI)

  5 and 10 days of rehabilitation activities

• Change in Modified Rankin scale (MRS) score

  5 and 10 days of rehabilitation activities

Study Arms (2)

Group 1

Patients that receive Cytoflavin® medication i/v drop infusion at a dose of 10 ml of solution for injection per 200 ml of 0.9 % sodium chloride solution for 10 days in addition to a set of neurorehabilitation activities

Group 2

Patients that subjected to the standard set of neurorehabilitation activities for 10 days without being prescribed Cytoflavin® medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The participants of the observational program will be male and female adults who underwent ischemic stroke NLT 12 and NMT 28 days before being admitted to the observational program with diagnosed PICS.

You may qualify if:

• Men and women aged 18 years and above;
• Patients who underwent ischemic stroke;
• The period from the development of ischemic stroke is not less than 12 and not more than 28 days;
• Staying in intensive care unit for no less than 72 hours;
• Diagnosed post-intensive care syndrome (PICS);
• Functional status assessed using the modified Rankin scale amounts to 4-5;

You may not qualify if:

• Vegetative state;
• Mechanical ventilation lasting more than 72 hours after the development of ischemic stroke;
• Surgical treatment for cerebral stroke (decompressive craniectomy; thromboextraction etc.);
• Premorbid (before the development of ischemic stroke) level of functional activity assessed using the modified Rankin scale amounts to 4 or 5;
• Level of consciousness ≤ 5 according to Glasgow Coma Scale and/or ≥ 1 according to Richmond Agitation-Sedation Scale (RASS);
• Systolic blood pressure \< 90 and \> 180 mm Hg;
• Diastolic blood pressure ≥ 110 mm Hg;
• Mean ABP \< 60 mm Hg;
• Acute heart arrhythmias;
• Heart rate (HR) \< 60 or \> 100 per minute;
• Spontaneous respiration rate (RR) \< 10 or \> 30 per minute;
• Arterial oxygen saturation (SpO2) \< 90 %;
• Venous serum glucose level ≤ 4 mmol/L;
• Axillary body temperature ≥ 38.5 °C;
• Hematocrit ≤ 30 %;

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (1)

Brain Institute Clinic

Yekaterinburg, Sverdlovsk Oblast, 623702, Russia

Location

Related Links

• Belkin AA, Leiderman IN, Kovalenko AL, Rizakhanova OA, Parfenov SA, Sapozhnikov KV. Cytoflavin as a modulator of rehabilitation treatment of patients with ischemic stroke complicated by post-intensive care syndrome. S.S. Korsakov Journal of Neurology and
• Belkin AA, Leiderman IN, Kovalenko AL, Rizakhanova OA, Parfenov SA, Sapozhnikov KV. Tsitoflavin kak komponent reabilitatsionnogo lecheniya patsientov s ishemicheskim insul'tom, oslozhnennym PIT-sindromom

MeSH Terms

Conditions

Ischemic Stroke; postintensive care syndrome

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andrey Belkin, Prof

  Brain Institute Clinic, Yekaterinburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: November 11, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

RU (1)