Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Dexmedetomidine on Intestine and Other Organ Damages After Cardiac Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786212
Recruitment Status : Unknown
Verified November 2016 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : May 30, 2016
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE May 18, 2016
First Posted Date  ICMJE May 30, 2016
Last Update Posted Date November 4, 2016
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
diamine oxidase concentration [ Time Frame: 1 hours after surgery ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
diamine oxidase concentration [ Time Frame: 6 hours after surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • diamine oxidase concentration [ Time Frame: 24 hours and 48 hours after surgery ]
  • endocam concentration [ Time Frame: 1 hours, 24 hours, and 48 hours after surgery ]
  • CC-16 concentration [ Time Frame: 1 hours, 24 hours, and 48 hours after surgery ]
  • cerebral tissue oxygen saturation (StO2) measured by NIRS [ Time Frame: 1 hours, 24 hours, and 48 hours after surgery ]
  • diamine oxidase concentration [ Time Frame: 10 minutes before anesthetic induction ]
  • endocam concentration [ Time Frame: 10 minutes before anesthetic induction ]
  • CC-16 concentration [ Time Frame: 10 minutes before anesthetic induction ]
  • diamine oxidase concentration [ Time Frame: 1 hour after start of cardiopulmonary bypass ]
  • endocam concentration [ Time Frame: 1 hour after start of cardiopulmonary bypass ]
  • CC-16 concentration [ Time Frame: 1 hour after start of cardiopulmonary bypass ]
  • cerebral tissue oxygen saturation (StO2) measured by NIRS [ Time Frame: 1 hour after start of cardiopulmonary bypass ]
  • diamine oxidase concentration [ Time Frame: 10 minutes after the end of cardiopulmonary bypass ]
  • Endocam concentration [ Time Frame: 10 minutes after the end of cardiopulmonary bypass ]
  • CC-16 concentration [ Time Frame: 10 minutes after the end of cardiopulmonary bypass ]
  • cerebral tissue oxygen saturation (StO2) measured by NIRS [ Time Frame: 10 minutes after the end of cardiopulmonary bypass ]
  • cerebral tissue oxygen saturation (StO2) measured by NIRS [ Time Frame: 10 minutes before anesthetic induction ]
  • perfused small vessel density [ Time Frame: 10 minutes before anesthetic induction ]
  • proportion of perfused small vessels [ Time Frame: 10 minutes before anesthetic induction ]
  • microvascular flow index [ Time Frame: 10 minutes before anesthetic induction ]
  • perfused small vessel density [ Time Frame: 1 hours after surgery ]
  • proportion of perfused small vessels [ Time Frame: 1 hours after surgery ]
  • microvascular flow index [ Time Frame: 1 hours after surgery ]
  • perfused small vessel density [ Time Frame: 24 hours after surgery ]
  • proportion of perfused small vessels [ Time Frame: 24 hours after surgery ]
  • microvascular flow index [ Time Frame: 24 hours after surgery ]
  • perfused small vessel density [ Time Frame: 48 hours after surgery ]
  • proportion of perfused small vessels [ Time Frame: 48 hours after surgery ]
  • microvascular flow index [ Time Frame: 48 hours after surgery ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
  • diamine oxidase concentration [ Time Frame: 24 hours and 48 hours after surgery ]
  • endocam concentration [ Time Frame: 6 hours, 24 hours, and 48 hours after surgery ]
  • CC-16 concentration [ Time Frame: 6 hours, 24 hours, and 48 hours after surgery ]
  • cerebral tissue oxygen saturation (StO2) measured by NIRS [ Time Frame: 6 hours, 24 hours, and 48 hours after surgery ]
  • diamine oxidase concentration [ Time Frame: 10 minutes before anesthetic induction ]
  • endocam concentration [ Time Frame: 10 minutes before anesthetic induction ]
  • CC-16 concentration [ Time Frame: 10 minutes before anesthetic induction ]
  • diamine oxidase concentration [ Time Frame: 1 hour after start of cardiopulmonary bypass ]
  • endocam concentration [ Time Frame: 1 hour after start of cardiopulmonary bypass ]
  • CC-16 concentration [ Time Frame: 1 hour after start of cardiopulmonary bypass ]
  • cerebral tissue oxygen saturation (StO2) measured by NIRS [ Time Frame: 1 hour after start of cardiopulmonary bypass ]
  • diamine oxidase concentration [ Time Frame: 10 minutes after the end of cardiopulmonary bypass ]
  • Endocam concentration [ Time Frame: 10 minutes after the end of cardiopulmonary bypass ]
  • CC-16 concentration [ Time Frame: 10 minutes after the end of cardiopulmonary bypass ]
  • cerebral tissue oxygen saturation (StO2) measured by NIRS [ Time Frame: 10 minutes after the end of cardiopulmonary bypass ]
  • cerebral tissue oxygen saturation (StO2) measured by NIRS [ Time Frame: 10 minutes before anesthetic induction ]
  • perfused small vessel density [ Time Frame: 10 minutes before anesthetic induction ]
  • proportion of perfused small vessels [ Time Frame: 10 minutes before anesthetic induction ]
  • microvascular flow index [ Time Frame: 10 minutes before anesthetic induction ]
  • perfused small vessel density [ Time Frame: 6 hours after surgery ]
  • proportion of perfused small vessels [ Time Frame: 6 hours after surgery ]
  • microvascular flow index [ Time Frame: 6 hours after surgery ]
  • perfused small vessel density [ Time Frame: 24 hours after surgery ]
  • proportion of perfused small vessels [ Time Frame: 24 hours after surgery ]
  • microvascular flow index [ Time Frame: 24 hours after surgery ]
  • perfused small vessel density [ Time Frame: 48 hours after surgery ]
  • proportion of perfused small vessels [ Time Frame: 48 hours after surgery ]
  • microvascular flow index [ Time Frame: 48 hours after surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Dexmedetomidine on Intestine and Other Organ Damages After Cardiac Surgeries
Official Title  ICMJE The Effects of Dexmedetomidine on Intestine and Other Organ Damages After Cardiac Surgeries
Brief Summary

Cardiac surgery with cardiopulmonary bypass (CPB) provokes a systemic inflammatory response that can often lead to dysfunction of major organs. Activation of the contact system, endotoxemia, surgical trauma, and ischemic reperfusion injury are all possible triggers of inflammation. Previous studies demonstrated that pro-inflammatory cytokines play an important role during this process. However, very little is known about the susceptibility of the splanchnic organs to ischemic reperfusion injury. Although the incidence of intestinal complications reported to be low, the in-hospital mortality in these patients was high at 15% to 63%.

Dexmedetomidine, a highly selective α2-adrenergic agonist, can reduce the consumption of other sedative and antinociceptive drugs and provide sufficient sedative effects with minimal respiratory side effects. In addition, dexmedetomidine gradually has gained popularity in the field of critical care. Preemptive administration of dexmedetomidine has shown to be protective against inflammation, intestinal, renal, and myocardial injuries in animal and human studies. Dexmedetomidine is also used as an anesthetic adjuvant during surgery to offer good perioperative hemodynamic stability and an intraoperative anesthetic-sparing effect. Perioperative use of dexmedetomidine can reduce intestinal and hepatic injury after hepatectomy with inflow occlusion under general anesthesia. However, whether or not it can exert protective effects on the above-mentioned organs, especially intestine, after cardiac surgery remains unclear. The aim of this study is to evaluate the effects of dexmedetomidine on intestinal, hepatic, and other organ injury in patients receiving cardiac surgery with CPB.

In this double-blinded randomized controlled study, serum diamine oxidase activity, which is a sensitive and specific marker for the detection of intestinal injury, is taken as the primary endpoint. Other parameters reflecting the functions of liver (AST/ALT), lung (lung injury score and CC-16), kidney (BUN/Cre), and heart (CK-MB/Troponin T), the biomarker of endothelial injury (endocan) will also be determined. Besides, microcirculation parameters measured with Cytocam® and near-infrared spectroscopy (NIRS) will be used to estimate the protective effect of dexmedetomidine on microcirculation. The variables will be collected perioperatively and will be followed up for 3 days after the surgery. Clinical outcome parameters will be followed up for 3 months after the surgery.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Surgical Procedure
Intervention  ICMJE
  • Drug: Dexmedetomidine
  • Drug: Normal Saline
Study Arms  ICMJE
  • Experimental: dexmedetomidine
    Patients receiving intraoperative dexmedetomidine infusion. Infusion duration: from 10 minutes after anesthetic induction to the end of surgery.
    Intervention: Drug: Dexmedetomidine
  • Placebo Comparator: control
    control group, receiving same volume of normal saline infusion.
    Intervention: Drug: Normal Saline
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 25, 2016)
70
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-emergent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  • left ventricle ejection fraction < 40%
  • acute myocardial infarction within 3 months
  • angina within 48 hours before surgery
  • COPD
  • previous history of inflammatory bowel disease
  • diarrhea within 7 days before surgery
  • previous cardiac surgery
  • receiving non-pharmacological cardiac supportive management
  • previous pulmonary embolism
  • previous deep vein thrombosis
  • allergic to dexmedetomidine
  • refractory bradycardia (HR < 60/min )
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (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 Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02786212
Other Study ID Numbers  ICMJE 201512224MINB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Po-Yuan Shih, MD Department of Anesthesiology, National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date November 2016

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