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Dexmedetomidine and Outcomes of Cardiac Surgery (DOCS) (DOCS)

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ClinicalTrials.gov Identifier: NCT02237495
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
chonglei, Xijing Hospital

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.

Condition or disease Intervention/treatment Phase
Heart Valve Diseases Coronary Artery Disease Drug: dexmedetomidine Drug: placebo Phase 2 Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Perioperative Infusion of Dexmedetomidine Improves Outcomes of Cardiovascular Surgery
Actual Study Start Date : April 9, 2014
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Saline
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
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.

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




Primary Outcome Measures :
  1. In-hospital all cause of mortality and major postoperative complications [ Time Frame: The participants will be tightly observed for the duration of hospital stay, an expected average of 10 days ]
    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 Outcome Measures :
  1. All cause mortality and major complications [ Time Frame: at 30 days and 1 year 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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237495


Locations
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China, Shaanxi
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
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Study Chair: Hailong Dong, M.D., Ph.D., Xijing Hospital

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Responsible Party: chonglei, M.D., PhD, Xijing Hospital
ClinicalTrials.gov Identifier: NCT02237495     History of Changes
Other Study ID Numbers: 20140227-5
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Coronary Artery Disease
Heart Valve Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dexmedetomidine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action