Ischemic StrokeNCT04194229
Cytoflavin in the Rehabilitation of Post-intensive Care Syndrome in Stroke Survivors
An observational study of Ischemic Stroke and Post Intensive Care Unit Syndrome, run by POLYSAN Scientific & Technological Pharmaceutical Company at 1 site in Russia.
Trial summary
Objective - to assess the effect of Cytoflavin® and its tolerability within the integrated program of rehabilitation of patients who underwent ischemic stroke Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Post Intensive Care Unit Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 11 Nov 2016to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
- Gravity gradient of 20° to 40° upon inclusion in observational non-interventional program
Who cannot join
- 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;
- Signs of increasing neurological deficit or enlargement of hypoperfusion zones on CT scans within 24 hours before inclusion in observational non-interventional program;
- Level of consciousness ≤ 5 according to Glasgow Coma Scale and/or ≥ 1 according to Richmond Agitation-Sedation Scale (RASS);
Show all 33Show fewer
- Behavioral Pain Scale (BPS) or Visual Analogue Scale assessment score of more than > 0 at the moment of inclusion;
- Systolic blood pressure < 90 and > 180 mm Hg;
- Diastolic blood pressure ≥ 110 mm Hg;
- Mean ABP < 60 mm Hg;
- Clinical and/or electrocardiographic signs of acute coronary syndrome (including de novo ST elevation or depression, negative T-waves amplitude formation and buildup, formation of pathological Q-wave, increase in the level of markers of myocardial injury - troponin T or I, creatine phosphokinase-MB, LDH-1), or diagnosed acute myocardial infarction occurring within a month before inclusion in observational program;
- 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 %;
- Level of hemoglobin ≤ 80 g/l;
- Serum total protein ≤ 55 g/l;
- Positive passive leg raising test (PRL-test);
- Acute heart failure;
- Acute respiratory failure;
- Acute kidney injury;
- Acute liver cell failure;
- Congestive heart failure;
- Chronic respiratory failure, stage greater than I;
- Chronic kidney disease with estimated glomerular filtration rate using Cockcroft-Gault formula < 60 ml/min/1.73 m2;
- Clinically significant deviations in the results of complete blood count, blood chemistry, common urine analysis, except those that are acceptable according to other non inclusion criteria;
- Purulent-inflammatory diseases at any location;
- Refuse of the patient to undergo verticalization or exercise sessions;
- Use of medicinal products belonging to the pharmaceutical therapeutic category of metabolic drugs at the time of inclusion in observational non-interventional program, as well as plans for their use during study;
- Plans for use of physical rehabilitation methods other than verticalization and cycling exercise sessions during the course of the program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Cytoflavin Solution at the Time of Early Rehabilitation in Patients With Post-intensive Care Syndrome Who Underwent Ischemic Stroke
Objective - to assess the effect of Cytoflavin® and its tolerability within the integrated program of rehabilitation of patients who underwent ischemic stroke
Read the detailed description
Cerebral stroke (CS) remains one of the key issues of modern society, being a predominant cause of deep and persistent disability of the population. Huge social and economic damage arising from cerebrovascular diseases raises the problem of improving medical care for strokes among the most relevant scientific and practical tasks of neurology Regulation of energy metabolism is considered a powerful tool for acute conditions relief, including those that occur due to acute impairment of cerebral blood flow. A number of adjuvant energy protector concomitant medications with systemic pharmacodynamic properties based on signaling (hormonal) and substrate mode of action of succinic acid and other mitochondrial substrates and co-factors was created for this A significant role in the rehabilitation of patients who underwent CS is assigned to the treatment of complications of care in the intensive care unit, the so-called post-intensive care syndrome (PICS), which is a set of somatic, neurological, social and psychological consequences of periods in intensive care unit (ICU) conditions that bring limitations to the patient's daily activities In the Brain Institute Clinic (Ekaterinburg), the first results of the metabolic status monitoring during physical and cognitive exercise in patients with PICS were obtained. These results prove that control over metabolic state holds the promise of developing approaches to increasing exercise tolerance Taking into account the effectiveness of Cytoflavin® in treatment of acute impairment of cerebral circulation and consequences of cerebrovascular diseases, on the one hand, and its classification as a metabotropic energy corrector, on the other hand, the evaluation of Cytoflavin® medication tolerability in the integrated program of neurorehabilitation of patients with PICS after ischemic stroke presents a significant interest.
- Conditions
- Ischemic Stroke, Post Intensive Care Unit Syndrome
- Keywords
- Ischemic stroke, Post-intensive care syndrome, Cytoflavin, Rehabilitation, Metabolograph, Utilization O2, Verticalization
- Medical subject headings
- Ischemic Stroke, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median time to achieving gravity gradient of 90°
Median time (in days) to achieving gravity gradient of 90°.
Measured: 10 days
Secondary outcomes (5)
Proportion of patients who achieved gravity gradient of 90°
Proportion of patients who achieved gravity gradient of 90° by day 5 and 10 days of rehabilitation activities
Measured: 5 and 10 days
Change in of oxygen consumption during 90° verticalization
Change in of oxygen consumption during 90° verticalization
Measured: 5 and 10 days
Change in the Medical Research Council (MRC) scale for muscle strength score
Medical Research Council scale for muscle power (MRC), where 0 - tetraplegia, 60 - normal value
Measured: 5 and 10 days
Change in Barthel index (BI)
Barthel index (BI), when 0 - complete inability to self-service, 100 - full capability of self-service
Measured: 5 and 10 days of rehabilitation activities
Change in Modified Rankin scale (MRS) score
Modified Rankin scale (MRS), when 0 - no disability, 5 - severe disability
Measured: 5 and 10 days of rehabilitation activities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start11 Nov 2016
- Primary completionJan 2021
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrey Belkin, Prof, Principal investigator, Brain Institute Clinic, Yekaterinburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194229
- Sponsor's protocol ID
- PR-C
- Status last verified
- Jul 2024
- First submitted
- 9 Dec 2019
- Last updated
- 19 Jul 2024
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Cytoflavin Solution at the Time of Early Rehabilitation in Patients With Post-intensive Care Syndrome Who Underwent Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04194229
- Acronym / sponsor ID
- PR-C
- Conditions
- Ischemic Stroke, Post Intensive Care Unit Syndrome
- Keywords
- Ischemic stroke, Post-intensive care syndrome, Cytoflavin, Rehabilitation, Metabolograph, Utilization O2, Verticalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective - to assess the effect of Cytoflavin® and its tolerability within the integrated program of rehabilitation of patients who underwent ischemic stroke
Detailed description
Cerebral stroke (CS) remains one of the key issues of modern society, being a predominant cause of deep and persistent disability of the population. Huge social and economic damage arising from cerebrovascular diseases raises the problem of improving medical care for strokes among the most relevant scientific and practical tasks of neurology Regulation of energy metabolism is considered a powerful tool for acute conditions relief, including those that occur due to acute impairment of cerebral blood flow. A number of adjuvant energy protector concomitant medications with systemic pharmacodynamic properties based on signaling (hormonal) and substrate mode of action of succinic acid and other mitochondrial substrates and co-factors was created for this A significant role in the rehabilitation of patients who underwent CS is assigned to the treatment of complications of care in the intensive care unit, the so-called post-intensive care syndrome (PICS), which is a set of somatic, neurological, social and psychological consequences of periods in intensive care unit (ICU) conditions that bring limitations to the patient's daily activities In the Brain Institute Clinic (Ekaterinburg), the first results of the metabolic status monitoring during physical and cognitive exercise in patients with PICS were obtained. These results prove that control over metabolic state holds the promise of developing approaches to increasing exercise tolerance Taking into account the effectiveness of Cytoflavin® in treatment of acute impairment of cerebral circulation and consequences of cerebrovascular diseases, on the one hand, and its classification as a metabotropic energy corrector, on the other hand, the evaluation of Cytoflavin® medication tolerability in the integrated program of neurorehabilitation of patients with PICS after ischemic stroke presents a significant interest.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (33 listed)
- 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;
- Signs of increasing neurological deficit or enlargement of hypoperfusion zones on CT scans within 24 hours before inclusion in observational non-interventional program;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median time to achieving gravity gradient of 90°
Time frame: 10 days
Median time (in days) to achieving gravity gradient of 90°.
5 secondary outcomes
Proportion of patients who achieved gravity gradient of 90°
Time frame: 5 and 10 days
Change in of oxygen consumption during 90° verticalization
Time frame: 5 and 10 days
Change in the Medical Research Council (MRC) scale for muscle strength score
Time frame: 5 and 10 days
Change in Barthel index (BI)
Time frame: 5 and 10 days of rehabilitation activities
Change in Modified Rankin scale (MRS) score
Time frame: 5 and 10 days of rehabilitation activities
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- 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 andLink provided by the sponsor.
- Belkin AA, Leiderman IN, Kovalenko AL, Rizakhanova OA, Parfenov SA, Sapozhnikov KV. Tsitoflavin kak komponent reabilitatsionnogo lecheniya patsientov s ishemicheskim insul'tom, oslozhnennym PIT-sindromomLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrey Belkin, Prof principal investigator
Brain Institute Clinic, Yekaterinburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Post Intensive Care Unit Syndrome, run by POLYSAN Scientific & Technological Pharmaceutical Company at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median time to achieving gravity gradient of 90° (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.