Patient Outcome AssessmentPhase 4NCT03091166
Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients
A Phase 4 study testing Dexmedetomidine in people with Patient Outcome Assessment, run by Moscow Regional Research and Clinical Institute (MONIKI) at 1 site in Russia.
Trial summary
Investigation of effect of perioperative Dexmedetomedine administration on mortality, length of ICU and hospital stay, delirium onset, major adverse cardiac and cerebrovascular events, acute kidney injury in cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patient Outcome Assessment
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2016to Apr 2019
- 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
- Written informed agreement
- Elective surgery
- Use of CPB
Who cannot join
- Previous prolonged immobilization
- Reoperation
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: The Effect of Prophylactic Dexmedetomidine Administration on the Outcome in Patients Undergoing Surgery With Cardiopulmonary Bypass
Investigation of effect of perioperative Dexmedetomedine administration on mortality, length of ICU and hospital stay, delirium onset, major adverse cardiac and cerebrovascular events, acute kidney injury in cardiac surgery patients.
- Conditions
- Patient Outcome Assessment
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexdor
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| No Dexmedetomidine | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
30DM
30-day mortality
Measured: 30 days after surgery
Delirium
Postoperative delirium
Measured: 30 days after surgery
Secondary outcomes (6)
VIS
Vasoactive- Inotropic Score
Measured: 5 days after surgery
MACCE
Major adverse cardiac and cerebrovascular events
Measured: 30 days after surgery
Subsyndromal delirium
Subsyndromal postoperative delirium
Measured: 30 days after surgery
AKI
Acute kidney injury
Measured: 7 days after surgery
ICU-LOS
Length of ICU stay
Measured: 7 days after surgery
H-LOS
Hospital length of stay
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startDec 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Outcome AssessmentStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oleg A. Grebenchikov, Moscow Regional Research and Clinical Institute (MONIKI)
- Investigators
- Valery Likhvantsev, Professor, Principal investigator, Moscow Regional Clinical and Research Institute, Moscow, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091166
- Sponsor's protocol ID
- PD-CS-2016
- Status last verified
- Apr 2019
- First submitted
- 21 Mar 2017
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prophylactic Dexmedetomidine Administration on the Outcome in Patients Undergoing Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT03091166
- Acronym / sponsor ID
- PD-CS-2016
- Conditions
- Patient Outcome Assessment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Moscow Regional Research and Clinical Institute (MONIKI)Other government
- Study start
- Dec 2016
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 27 Mar 2017 (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.
Investigation of effect of perioperative Dexmedetomedine administration on mortality, length of ICU and hospital stay, delirium onset, major adverse cardiac and cerebrovascular events, acute kidney injury in cardiac surgery patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine |
| No Dexmedetomidine | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed agreement
- Elective surgery
- Use of CPB
Key exclusion criteria (2 listed)
- Previous prolonged immobilization
- Reoperation
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 |
|---|---|---|
| DexmedetomidineAlso: Dexdor | Drug | Dexmedetomidine |
Primary outcome
30DM
Time frame: 30 days after surgery
30-day mortality
Delirium
Time frame: 30 days after surgery
Postoperative delirium
6 secondary outcomes
VIS
Time frame: 5 days after surgery
MACCE
Time frame: 30 days after surgery
Subsyndromal delirium
Time frame: 30 days after surgery
AKI
Time frame: 7 days after surgery
ICU-LOS
Time frame: 7 days after surgery
H-LOS
Time frame: 30 days after surgery
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 11 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Patient Outcome Assessment
Recruiting
Effect of Rutin and Vitamin C on Outcomes in Adults With Sepsis Admitted to the Intensive Care Unit
Sepsis
Not yet recruitingObservational study
Automated Capture of Core Data for Rare Diseases and Glucocorticoid Complications: Biomarkers and Patient-Reported Outcomes
Cushing s Syndrome, Glucocorticoid Effect
Not yet recruitingObservational study
Comparative Effectiveness and Safety of Two Hyaluronic Acid Products in Knee Osteoarthritis
Osteoarthritis, Knee
RecruitingObservational study
Characteristics and Outcomes of Patients Admitted to ICU for a Severe Acute Exacerbation of COPD.
COPD Exacerbation, ICU
Active, not recruitingObservational study
Skeletal Muscle Biomarkers in People With Fragile Sarcolemmal Muscular Dystrophy
Genetic Disorder
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.
Valery Likhvantsev, Professor principal investigator
Moscow Regional Clinical and Research Institute, Moscow, Russia
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 Dexmedetomidine in people with Patient Outcome Assessment, 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 3 inclusion and 2 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 11 Apr 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 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?
30DM (time frame: 30 days after surgery). The study lists 2 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 11 Apr 2019.