NCT02237495

Brief Summary

Cardiac surgery is associated with a high risk of cardiovascular and other complications. The investigators hypothesized that perioperative infusion of dexmedetomidine may reduce the incidence of complications and mortality following cardiovascular surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,100

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2014

Typical duration for phase_2

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

April 9, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2018

Enrollment Period

2.9 years

First QC Date

August 18, 2014

Last Update Submit

July 5, 2020

Conditions

Heart Valve DiseasesCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 1-year all cause of mortality and major postoperative complications

    Postoperative delirium, infection, acute renal failure (ARF) and major adverse cardiocerebral events (MACE) which includes permanent or transient stroke, coma, perioperative myocardial infarction (MI), heart block and cardiac arrest represent major postoperative complications.

    1 year after operation

Secondary Outcomes (1)

  • All cause mortality and major complications

    The participants will be tightly observed for the duration of hospital stay, an expected average of 10 days and at 30 days after operation,

Other Outcomes (3)

  • postoperative hospital stay

    the number of days between the operation and discharge, an expected average of 12 days

  • ICU-stay

    the number of days the patients stay in the ICU after surgery, an expected average of 3 days

  • Incidence of prolonged ventilation

    the duration of intubation is the time from trachea intubation to extubation, an expected average of 20 hours

Study Arms (2)

Saline

PLACEBO COMPARATOR

Normal saline as placebo is continuously infused right after anesthesia induction and lasts for 12 hrs with the same infusion rate as the comparator dexmedetomidine

Drug: placebo

dexmedetomidine

EXPERIMENTAL

dexmedetomidine intravenous infusion starts right after anesthesia induction in the operating room and last for 12 hours into ICU with a infusion dose of 0.4 ug/kg/h. To avoid potential cause of bradycardia, no dexmedetomidine bolus is given.

Drug: dexmedetomidine

Interventions

dexmedetomidineDRUG

dexmedetomidine with the dose of 0.4 ug/kg/h is continuously infused right after anesthesia induction and lasts for 12 hrs.

Also known as: Precedex
dexmedetomidine
placeboDRUG

The vehicle of dexmedetomidine, normal saline is continuously infused right after anesthesia induction and lasts for 12 hrs with the same rate of the treatment arm.

Saline

Eligibility Criteria

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

You may qualify if:

  • Provide written informed consent
  • Are \> 18 years of age
  • Elective cardiac surgery with CPB, when the surgeon plans to do valve and/or CABG surgery

You may not qualify if:

  • Emergent cardiac surgery
  • Other than CABG and/or Valve surgery
  • off-pump or robotic surgery
  • Surgery requiring deep hypothermic circulatory arrest or involving the thoracic aorta
  • Life expectancy \< 1 year
  • Preop severe liver or renal dysfunction, with replacement therapy required
  • Patients with IABP or with cardiogenic shock
  • Severe dehydrate or dystrophia or Hb \< 10 g/dl
  • History of any alpha-2 receptor agonists allergy.
  • Refuse to provide written informed consent
  • Diagnosed with mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • Lei C, Zheng Z, Han J, Wang L, Zhai W, Li C, Hou L, Yu S, Liu J, Xu X, Wang S, Guo X, Zhang T, Zhou J, Zou J, Tian Y, Chi X, Qiu L, Xu M, Zhang X, Huang W, Chen Y, Yan M, Wang H, Xia J, Wang L, Liu H, Dong H. Effects of Dexmedetomidine on Outcomes After Cardiac Surgery (DOCS): a randomised double-blind, placebo-controlled trial. Br J Anaesth. 2026 Jan;136(1):55-64. doi: 10.1016/j.bja.2025.09.026. Epub 2025 Nov 14.

    PMID: 41238464DERIVED

MeSH Terms

Conditions

Heart Valve DiseasesCoronary Artery Disease

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hailong Dong, M.D., Ph.D.,

    Xijing Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., PhD

Study Record Dates

First Submitted

August 18, 2014

First Posted

September 11, 2014

Study Start

April 9, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

July 8, 2020

Record last verified: 2018-07

Locations

CN(1)