Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients

Patient Outcome Assessment Clinical Trial

Official title:

The Effect of Prophylactic Dexmedetomidine Administration on the Outcome in Patients Undergoing Surgery With Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091166
• Other study ID #: PD-CS-2016
• Status: Completed
• Phase: Phase 4
• Start date: December 2016
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Written informed agreement

• Elective surgery

• Use of CPB

Exclusion Criteria:

• Previous prolonged immobilization

• Reoperation

Related Conditions & MeSH terms

• Patient Outcome Assessment

Intervention

Drug:
• Dexmedetomidine

Locations

Country	Name	City	State
Russian Federation	Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy	Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30DM	30-day mortality	30 days after surgery
Primary	Delirium	Postoperative delirium	30 days after surgery
Secondary	VIS	Vasoactive- Inotropic Score	5 days after surgery
Secondary	MACCE	Major adverse cardiac and cerebrovascular events	30 days after surgery
Secondary	Subsyndromal delirium	Subsyndromal postoperative delirium	30 days after surgery
Secondary	AKI	Acute kidney injury	7 days after surgery
Secondary	ICU-LOS	Length of ICU stay	7 days after surgery
Secondary	H-LOS	Hospital length of stay	30 days after surgery