NCT03091166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

2.3 years

First QC Date

March 21, 2017

Last Update Submit

April 10, 2019

Conditions

Patient Outcome Assessment

Outcome Measures

Primary Outcomes (2)

  • 30DM

    30-day mortality

    30 days after surgery

  • Delirium

    Postoperative delirium

    30 days after surgery

Secondary Outcomes (6)

  • VIS

    5 days after surgery

  • MACCE

    30 days after surgery

  • Subsyndromal delirium

    30 days after surgery

  • AKI

    7 days after surgery

  • ICU-LOS

    7 days after surgery

  • +1 more secondary outcomes

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR
Drug: Dexmedetomidine

No Dexmedetomidine

NO INTERVENTION

Interventions

DexmedetomidineDRUG
Also known as: Dexdor
Dexmedetomidine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed agreement
  • Elective surgery
  • Use of CPB

You may not qualify if:

  • Previous prolonged immobilization
  • Reoperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

Moscow, 129110, Russia

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Valery Likhvantsev, Professor

    Moscow Regional Clinical and Research Institute, Moscow, Russia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior researcher

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 27, 2017

Study Start

December 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 11, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)