Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients

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

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:
  • Dexdor
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

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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