Dexmedetomidine and Outcomes of Cardiac Surgery (DOCS)

Coronary Artery Disease Clinical Trial

— DOCS  

Official title:

Perioperative Infusion of Dexmedetomidine Improves Outcomes of Cardiovascular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237495
• Other study ID #: 20140227-5
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 9, 2014
• Est. completion date: March 2018

Study information

• Verified date: July 2018
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

There are about 694,000 open-heart surgeries performed in US each year. The major complication rates for valve plus coronary artery bypass graft (CABG) procedure are as high as 30.1% in Society of Thoracic Surgeons (STS) reports. Postoperative delirium, infection, acute renal failure (ARF) and major adverse cardiocerebral events (MACE) which include permanent or transient stroke, coma, perioperative myocardial infarction (MI), heart block and cardiac arrest represent the major postoperative complications. These complications translate into increased mortality and prolonged hospital stays with estimated costs exceeding $20 billion annually.6 The etiologies of these adverse events are multifactorial, but one major contributing factor is the surgical stress responses that result in increasing plasma levels of epinephrine and norepinephrine, with consequent myocardial oxygen supply demand imbalance and myocardial ischemia. More than 50% of all perioperative complications are related to adverse cardiovascular events.

The alpha-2 receptor agonists (clonidine, dexmedetomidine) currently used in clinical practice have many desirable effects that may provide myocardial protection including analgesia, anxiolysis, inhibition of central sympathetic outflow and reduction of systemic norepinephrine release that improve hemodynamic stability and positively affect myocardial oxygen supply and demand. The most widely studied alpha-2 agonist is clonidine, a long-acting partial agonist with an alpha-2 to alpha-1 selectivity ratio of 39:1. However, dexmedetomidine is a highly selective, shorter-acting intravenous alpha-2 agonist with an alpha-2 to alpha-1 selectivity ratio of 1300:1.

Multiple studies have reported that dexmedetomidine has a protective effect on specific organs including heart, brain, kidney and lungs. In addition, dexmedetomidine has been shown to have anti-inflammatory properties decreasing mortality and attenuating plasma cytokine concentrations in laboratory animals exposed to endotoxin in a dose-dependent fashion. The investigators hypothesized that dexmedetomidine may provide myocardial, brain, renal and immune function protection for cardiovascular surgical patients. The specific aim of this study was to investigate whether the perioperative use of dexmedetomidine is associated with improved outcomes and a decreased incidence in postoperative mortality, MACE or other complications in patients undergoing open-heart surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: March 2018
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Valve Diseases

Intervention

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

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative hospital stay	Record the time of post operative stay	the number of days between the operation and discharge, an expected average of 12 days
Other	ICU-stay	It is the length of stay in ICU	the number of days the patients stay in the ICU after surgery, an expected average of 3 days
Other	Incidence of prolonged ventilation	Prolonged ventilation is defined as patients remaining on the ventilator for more than 48 hours	the duration of intubation is the time from trachea intubation to extubation, an expected average of 20 hours
Primary	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	All cause mortality and major complications	Infection, renal failure, need for dialysis, and major adverse cardiocerebral events (MACE) which includes permanent or transient stroke, coma, perioperative myocardial infarction (MI), heart block and cardiac arrest represent 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,