- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03091166
Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients
April 10, 2019 updated by: Oleg A. Grebenchikov, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
169
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Moscow, Russian Federation, 129110
- Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written informed agreement
- Elective surgery
- Use of CPB
Exclusion Criteria:
- Previous prolonged immobilization
- Reoperation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dexmedetomidine
|
Other Names:
|
No Intervention: No Dexmedetomidine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30DM
Time Frame: 30 days after surgery
|
30-day mortality
|
30 days after surgery
|
Delirium
Time Frame: 30 days after surgery
|
Postoperative delirium
|
30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VIS
Time Frame: 5 days after surgery
|
Vasoactive- Inotropic Score
|
5 days after surgery
|
MACCE
Time Frame: 30 days after surgery
|
Major adverse cardiac and cerebrovascular events
|
30 days after surgery
|
Subsyndromal delirium
Time Frame: 30 days after surgery
|
Subsyndromal postoperative delirium
|
30 days after surgery
|
AKI
Time Frame: 7 days after surgery
|
Acute kidney injury
|
7 days after surgery
|
ICU-LOS
Time Frame: 7 days after surgery
|
Length of ICU stay
|
7 days after surgery
|
H-LOS
Time Frame: 30 days after surgery
|
Hospital length of stay
|
30 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Valery Likhvantsev, Professor, Moscow Regional Clinical and Research Institute, Moscow, Russia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
April 1, 2019
Study Registration Dates
First Submitted
March 21, 2017
First Submitted That Met QC Criteria
March 21, 2017
First Posted (Actual)
March 27, 2017
Study Record Updates
Last Update Posted (Actual)
April 11, 2019
Last Update Submitted That Met QC Criteria
April 10, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- PD-CS-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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