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

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cardiac Surgical Procedure Drug: Dexmedetomidine Drug: Normal Saline Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Dexmedetomidine on Intestine and Other Organ Damages After Cardiac Surgeries
Study Start Date : September 2016
Estimated Primary Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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Arm Intervention/treatment
Experimental: dexmedetomidine
Patients receiving intraoperative dexmedetomidine infusion. Infusion duration: from 10 minutes after anesthetic induction to the end of surgery.
 Drug: Dexmedetomidine
Placebo Comparator: control
control group, receiving same volume of normal saline infusion.
 Drug: Normal Saline


Outcome Measures
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Primary Outcome Measures :
  1. diamine oxidase concentration [ Time Frame: 1 hours after surgery ]

Secondary Outcome Measures :
  1. diamine oxidase concentration [ Time Frame: 24 hours and 48 hours after surgery ]
  2. endocam concentration [ Time Frame: 1 hours, 24 hours, and 48 hours after surgery ]
  3. CC-16 concentration [ Time Frame: 1 hours, 24 hours, and 48 hours after surgery ]
  4. cerebral tissue oxygen saturation (StO2) measured by NIRS [ Time Frame: 1 hours, 24 hours, and 48 hours after surgery ]
  5. diamine oxidase concentration [ Time Frame: 10 minutes before anesthetic induction ]
  6. endocam concentration [ Time Frame: 10 minutes before anesthetic induction ]
  7. CC-16 concentration [ Time Frame: 10 minutes before anesthetic induction ]
  8. diamine oxidase concentration [ Time Frame: 1 hour after start of cardiopulmonary bypass ]
  9. endocam concentration [ Time Frame: 1 hour after start of cardiopulmonary bypass ]
  10. CC-16 concentration [ Time Frame: 1 hour after start of cardiopulmonary bypass ]
  11. cerebral tissue oxygen saturation (StO2) measured by NIRS [ Time Frame: 1 hour after start of cardiopulmonary bypass ]
  12. diamine oxidase concentration [ Time Frame: 10 minutes after the end of cardiopulmonary bypass ]
  13. Endocam concentration [ Time Frame: 10 minutes after the end of cardiopulmonary bypass ]
  14. CC-16 concentration [ Time Frame: 10 minutes after the end of cardiopulmonary bypass ]
  15. cerebral tissue oxygen saturation (StO2) measured by NIRS [ Time Frame: 10 minutes after the end of cardiopulmonary bypass ]
  16. cerebral tissue oxygen saturation (StO2) measured by NIRS [ Time Frame: 10 minutes before anesthetic induction ]
  17. perfused small vessel density [ Time Frame: 10 minutes before anesthetic induction ]
  18. proportion of perfused small vessels [ Time Frame: 10 minutes before anesthetic induction ]
  19. microvascular flow index [ Time Frame: 10 minutes before anesthetic induction ]
  20. perfused small vessel density [ Time Frame: 1 hours after surgery ]
  21. proportion of perfused small vessels [ Time Frame: 1 hours after surgery ]
  22. microvascular flow index [ Time Frame: 1 hours after surgery ]
  23. perfused small vessel density [ Time Frame: 24 hours after surgery ]
  24. proportion of perfused small vessels [ Time Frame: 24 hours after surgery ]
  25. microvascular flow index [ Time Frame: 24 hours after surgery ]
  26. perfused small vessel density [ Time Frame: 48 hours after surgery ]
  27. proportion of perfused small vessels [ Time Frame: 48 hours after surgery ]
  28. microvascular flow index [ Time Frame: 48 hours after surgery ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 )
Contacts and Locations
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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): NCT02786212


Contacts
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Contact: Po-Yuan Shih, MD 886-2-23123456 ext 62158 shih.poyuan@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Po-Yuan Shih, MD    886-2-23123456 ext 62158    shih.poyuan@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Po-Yuan Shih, MD Department of Anesthesiology, National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02786212    
Other Study ID Numbers: 201512224MINB
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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