Effect of Dexmedetomidine on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
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|ClinicalTrials.gov Identifier: NCT02698930|
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : January 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Infective Endocarditis||Drug: dexmedetomidine Drug: Normal saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
|Experimental: dexmedetomidine group||
Randomly selected patients of the dexmedetomidine group are given intravenous 0.4mcg/kg/h of dexmedetomidine from the beginning of the anesthesia to postoperative 1 day.
|Placebo Comparator: Control group||
Drug: Normal saline
Group given intravenous 0.4mcg/kg/h of normal saline from the beginning of the anesthesia to postoperative 1 day.
- The incidence of acute kidney injury [ Time Frame: 1 week ]
- 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.
- Major adverse kidney events (MAKE) [ Time Frame: 3month, 1 year ]
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): NCT02698930
|Korea, Republic of|
|Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Jae-Kwang Shim, MD 82-2-2228-8500 ANESHIM@yuhs.ac|