Skip to main content
OpenTrials
Completed

NCT Number: NCT02237495

Dexmedetomidine and Outcomes of Cardiac Surgery (DOCS)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex

Placebo

Drug

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.

Primary outcomes

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

    Time frame: 1 year after operation

    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.

Secondary outcomes

  1. All cause mortality and major complications

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

    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

Other outcomes

  1. postoperative hospital stay

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

    Record the time of post operative stay

  2. ICU-stay

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

    It is the length of stay in ICU

  3. Incidence of prolonged ventilation

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

    Prolonged ventilation is defined as patients remaining on the ventilator for more than 48 hours

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Perioperative Infusion of Dexmedetomidine Improves Outcomes of Cardiovascular Surgery

Acronym: DOCS

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Sep 11, 2014
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.