Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients

Phase 4

Completed

• Conditions: Patient Outcome Assessment
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT03091166
• Lead Sponsor: Moscow Regional Research and Clinical Institute (MONIKI)

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 available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Status Verified: 2019-04
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

• Written informed agreement
• Elective surgery
• Use of CPB

Exclusion Criteria

• Previous prolonged immobilization
• Reoperation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Delirium	30 days after surgery	Postoperative delirium
30DM	30 days after surgery	30-day mortality

Secondary Outcome Measures

Name	Time	Method
AKI	7 days after surgery	Acute kidney injury
VIS	5 days after surgery	Vasoactive- Inotropic Score
Subsyndromal delirium	30 days after surgery	Subsyndromal postoperative delirium
ICU-LOS	7 days after surgery	Length of ICU stay
H-LOS	30 days after surgery	Hospital length of stay
MACCE	30 days after surgery	Major adverse cardiac and cerebrovascular events

Trial Locations

Locations (1)

Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy; 🇷🇺 Moscow, Russian Federation