Glycogen Synthase Kinase 3Phase 4NCT02686710
Comparison of the Effects of TIVA vs VIMA on Content of GSK-3beta in Leucocytes in On-pump Patients
A Phase 4 study testing Sevoflurane and Propofol in people with Glycogen Synthase Kinase 3, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
Trial summary
Assessment of GSK-3beta contents in leukocytes in on-pump cardiosurgical patients receiving either volatile or intravenous anesthesia Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glycogen Synthase Kinase 3
- What is being tested?
- Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2016to Dec 2018
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective on-pump CABG
Who cannot join
- re-operation
Trial locations and contacts
1 site in 1 country.
Russia1 site
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
Moscow, 129110
About this study
Official title: Comparison of the Effects of TIVA vs VIMA on Content of GSK-3beta in Leucocytes in On-pump Patients: a Randomized Clinical Trial
Assessment of GSK-3beta contents in leukocytes in on-pump cardiosurgical patients receiving either volatile or intravenous anesthesia
- Conditions
- Glycogen Synthase Kinase 3
- Being tested
- Sevoflurane, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
PropofolDrug
| Study group | Role | What they receive |
|---|---|---|
| VIMA | Active comparator | Patiens receiving volatile induction and maitenance of anesthesia Receives: Drug: Sevoflurane |
| TIVA | Active comparator | Patiens receiving total intravenous anesthesia based on propofol Receives: Drug: Propofol |
| Combi | Active comparator | Patiens receiving total intravenous induction and volatile anesthesia Receives: Drug: Sevoflurane; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gsk-3beta base line content
Measured: base line
Gsk-3beta content after induction
Measured: 20 minutes after tracheal intubation
Gsk-3beta content after surgery
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycogen Synthase Kinase 3Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Valery V. Likhvantsev, Professor, Moscow Regional Research and Clinical Institute (MONIKI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686710
- Sponsor's protocol ID
- GSK-TV-L
- Status last verified
- Aug 2019
- First submitted
- 16 Feb 2016
- Last updated
- 15 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of TIVA vs VIMA on Content of GSK-3beta in Leucocytes in On-pump Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02686710
- Acronym / sponsor ID
- GSK-TV-L
- Conditions
- Glycogen Synthase Kinase 3
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)Other government
- Study start
- Feb 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 19 Feb 2016 (estimated)
- 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.
Assessment of GSK-3beta contents in leukocytes in on-pump cardiosurgical patients receiving either volatile or intravenous anesthesia
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VIMA | Active comparator | Drug: SevofluranePatiens receiving volatile induction and maitenance of anesthesia |
| TIVA | Active comparator | Drug: PropofolPatiens receiving total intravenous anesthesia based on propofol |
| Combi | Active comparator | Drug: Sevoflurane, Drug: PropofolPatiens receiving total intravenous induction and volatile anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective on-pump CABG
Key exclusion criteria (1 listed)
- re-operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevoflurane | Drug | Combi, VIMA |
| Propofol | Drug | Combi, TIVA |
Primary outcome
Gsk-3beta base line content
Time frame: base line
Gsk-3beta content after induction
Time frame: 20 minutes after tracheal intubation
Gsk-3beta content after surgery
Time frame: immediately after surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and Propofol in people with Glycogen Synthase Kinase 3, run by Moscow Regional Research and Clinical Institute (MONIKI) 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 15 Aug 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Gsk-3beta base line content (time frame: base line). The study lists 3 primary outcomes in all. 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 15 Aug 2019.