Effect of Perioperative Dexmedetomidine Administration on... | NCT03091166

Studies
Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients

NCT03091166

Sponsor

Moscow Regional Research and Clinical Institute (MONIKI)

Status

Completed

Last Update Posted

Apr 11, 2019Actual

Enrollment

169Actual

Phase

Phase 4

Conditions

Patient Outcome Assessment

Interventions

Dexmedetomidine

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Apr 2019Actual

Completion Date

Apr 2019Actual

First Submitted Date

Mar 21, 2017

First Submission Date that Met QC Criteria

Mar 21, 2017

First Posted Date

Mar 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2019

Last Update Posted Date

Apr 11, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oleg A. Grebenchikov, senior researcher, Moscow Regional Research and Clinical Institute (MONIKI)Principal Investigator

Lead Sponsor

Moscow Regional Research and Clinical Institute (MONIKI)OTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

169Actual

Label	Type	Description	Intervention Names
Dexmedetomidine	Active Comparator		Drug: Dexmedetomidine
No Dexmedetomidine	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug		Dexmedetomidine	Dexdor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
30DM	30-day mortality	30 days after surgery
Delirium	Postoperative delirium	30 days after surgery

Secondary Outcomes

Measure	Description	Time Frame
VIS	Vasoactive- Inotropic Score	5 days after surgery
MACCE	Major adverse cardiac and cerebrovascular events	30 days after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed agreement
Elective surgery
Use of CPB

Exclusion Criteria:

Previous prolonged immobilization
Reoperation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Valery Likhvantsev, Professor	Moscow Regional Clinical and Research Institute, Moscow, Russia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy		Moscow		129110	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided