Clinical trial NCT02698930: Effect of Dexmedetomidine on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infective Endocarditis
Keywords: Infective endocarditis
acute kidney injury
dexmedetomidine
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 94
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 and the incidence of major adverse kidney events (MAKE) after open heart surgery due to infective endocarditis and the level of inflammatory mediators.

The primary end point of this study is the incidence of acute kidney injury after open heart surgery due to infective endocarditis. And secondary end point is the incidence of MAKE, the level of cystatin C which is related to the renal function, the level of inflammatory mediator and the postoperative morbidities.


Eligibility criteria: Inclusion Criteria:

* patients with infective endocarditis
* patients who are scheduled to undergo open heart surgery

Exclusion Criteria:

* chronic kidney disease
* taking high dose steroid (\>10mg/day prednisolone or equivalent)
* age under 20 years
* cognitive dysfunction
* disabling mental change disorder
* unable to communicate or speak Korean

Primary outcomes:
measure: The incidence of acute kidney injury
timeFrame: 1 week
Secondary outcomes:
measure: Cystatin C level
timeFrame: postoperative day 1,2,3 and 5
measure: inflammatory mediator(IL-6) level
timeFrame: postoperative day 1,2,3 and 5
measure: inflammatory mediator(CRP) level
timeFrame: postoperative day 1,2,3 and 5
measure: inflammatory mediator(WBC) level
timeFrame: postoperative day 1,2,3 and 5
measure: inflammatory mediator(neutrophil count) level
timeFrame: postoperative day 1,2,3 and 5
measure: serum norepinephrine/epinephrine level(ng/mL)
timeFrame: postoperative day 1,2,3 and 5
measure: intraoperative hemodynamics measured by amount of used vasopressors(mL)
timeFrame: postoperative day 1,2,3 and 5
measure: intraoperative fluid intake and output
timeFrame: postoperative day 1,2,3 and 5
measure: postoperative complications
timeFrame: postoperative day 1,2,3 and 5
measure: Major adverse kidney events (MAKE)
timeFrame: 3month, 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Rosner MH, Portilla D, Okusa MD. Cardiac surgery as a cause of acute kidney injury: pathogenesis and potential therapies. J Intensive Care Med. 2008 Jan-Feb;23(1):3-18. doi: 10.1177/0885066607309998.
citation: Conlon PJ, Jefferies F, Krigman HR, Corey GR, Sexton DJ, Abramson MA. Predictors of prognosis and risk of acute renal failure in bacterial endocarditis. Clin Nephrol. 1998 Feb;49(2):96-101.
citation: Ren J, Zhang H, Huang L, Liu Y, Liu F, Dong Z. Protective effect of dexmedetomidine in coronary artery bypass grafting surgery. Exp Ther Med. 2013 Aug;6(2):497-502. doi: 10.3892/etm.2013.1183. Epub 2013 Jun 25.