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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

Tracking Information
First Submitted Date  ICMJE August 18, 2014
First Posted Date  ICMJE September 11, 2014
Last Update Posted Date July 3, 2018
Actual Study Start Date  ICMJE April 9, 2014
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02237495 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 8, 2014)
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine and Outcomes of Cardiac Surgery (DOCS)
Official Title  ICMJE Perioperative Infusion of Dexmedetomidine Improves Outcomes of Cardiovascular Surgery
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Heart Valve Diseases
  • Coronary Artery Disease
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Drug: placebo
  • 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.
    Intervention: Drug: dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2018)
1100
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2014)
1000
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02237495
Other Study ID Numbers  ICMJE 20140227-5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party chonglei, Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hailong Dong, M.D., Ph.D., Xijing Hospital
PRS Account Xijing Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP