Clinical Trial: Effect of Dexmedetomidine on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title:

Brief Summary:

Acute kidney injury is major complication after open heart surgery. The cause of acute kidney injury following open heart surgery is related to activation of sympathetic nervous system, decrease of renal blood flow, ischemia-reperfusion injury and systemic inflammatory response.

Infective endocarditis patients undergoing open heart surgery have systemic inflammatory response associated with infective endocarditis. And the inflammatory response can be aggravated by cardiopulmonary bypass. The incidence of acute kidney injury following open heart surgery due to infective endocarditis was 50% in a previous report. And this acute kidney injury was related to the poor outcome and high mortality. Thus, the preventive method to protect kidney function will be needed in the patients with infective endocarditis undergoing open heart surgery.

Dexmedetomidine is a selective α2-agonist and has sedative, analgesic, and CNS depressive effect. And several experimental study demonstrated the renal protective effect. Intraoperative dexmedetomidine administration can reduce the amount of anesthetics needed and suppress the sympathetic response resulted by surgical stimulation. And dexmedetomidine was reported to reduce the level of serum cortisol, epinephrine and norepinephrine during the operation. Thus, these effects of dexmedetomidine can be expected to reduce the incidence of acute kidney injury.

Therefore, the investigators hypothesized that dexmedetomidine has renal protective effect and this effect might be related to the suppression of inflammatory response. Thus, the investigators will evaluate the incidence of acute kidney injury after open heart surgery due to infective endocarditis and the level of inflammatory mediators.

The

Detailed Summary:
Sponsor: Yonsei University

Current Primary Outcome: The incidence of acute kidney injury [ Time Frame: 1 week ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cystatin C level [ Time Frame: postoperative day 1,2,3 and 5 ]
    serum cystatin C level (mg/L)
  • inflammatory mediator(IL-6) level [ Time Frame: postoperative day 1,2,3 and 5 ]
    serum inflammatory mediator (IL-6(pg/mL)
  • inflammatory mediator(CRP) level [ Time Frame: postoperative day 1,2,3 and 5 ]
    serum inflammatory mediator (CRP(mg/L))
  • inflammatory mediator(WBC) level [ Time Frame: postoperative day 1,2,3 and 5 ]
    Serum WBC(/microL) level
  • inflammatory mediator(neutrophil count) level [ Time Frame: postoperative day 1,2,3 and 5 ]
    serum inflammatory mediator (neutrophil count(/microL)) level
  • serum norepinephrine/epinephrine level(ng/mL) [ Time Frame: postoperative day 1,2,3 and 5 ]
  • intraoperative hemodynamics measured by amount of used vasopressors(mL) [ Time Frame: postoperative day 1,2,3 and 5 ]
  • intraoperative fluid intake and output [ Time Frame: postoperative day 1,2,3 and 5 ]
    intraoperative intake and output measured by the amount of fluid(crystalloid/colloid)(mL) and blood administered(mL)
  • postoperative complications [ Time Frame: postoperative day 1,2,3 and 5 ]
    postoperative complications such as development of myocardial infarction, arrhythmia, cerebrovascular accident, wound infection, and mortality.


Original Secondary Outcome: Same as current

Information By: Yonsei University

Dates:
Date Received: February 15, 2016
Date Started: February 2016
Date Completion: October 2018
Last Updated: February 29, 2016
Last Verified: February 2016