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Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03091166
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Oleg A. Grebenchikov, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

Brief 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.

Condition or disease Intervention/treatment Phase
Patient Outcome Assessment Drug: Dexmedetomidine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Prophylactic Dexmedetomidine Administration on the Outcome in Patients Undergoing Surgery With Cardiopulmonary Bypass
Study Start Date : December 2016
Actual Primary Completion Date : April 2019
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Active Comparator: Dexmedetomidine Drug: Dexmedetomidine
Other Name: Dexdor

No Intervention: No Dexmedetomidine



Primary Outcome Measures :
  1. 30DM [ Time Frame: 30 days after surgery ]
    30-day mortality

  2. Delirium [ Time Frame: 30 days after surgery ]
    Postoperative delirium


Secondary Outcome Measures :
  1. VIS [ Time Frame: 5 days after surgery ]
    Vasoactive- Inotropic Score

  2. MACCE [ Time Frame: 30 days after surgery ]
    Major adverse cardiac and cerebrovascular events

  3. Subsyndromal delirium [ Time Frame: 30 days after surgery ]
    Subsyndromal postoperative delirium

  4. AKI [ Time Frame: 7 days after surgery ]
    Acute kidney injury

  5. ICU-LOS [ Time Frame: 7 days after surgery ]
    Length of ICU stay

  6. H-LOS [ Time Frame: 30 days after surgery ]
    Hospital length of stay



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed agreement
  • Elective surgery
  • Use of CPB

Exclusion Criteria:

  • Previous prolonged immobilization
  • Reoperation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091166


Locations
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Russian Federation
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
Moscow, Russian Federation, 129110
Sponsors and Collaborators
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
Investigators
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Principal Investigator: Valery Likhvantsev, Professor Moscow Regional Clinical and Research Institute, Moscow, Russia

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Responsible Party: Oleg A. Grebenchikov, senior researcher, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
ClinicalTrials.gov Identifier: NCT03091166    
Other Study ID Numbers: PD-CS-2016
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action