Effect of Dexmedetomidine on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
- Registration Number
- NCT02698930
- Lead Sponsor
- Yonsei University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 94
- patients with infective endocarditis
- patients who are scheduled to undergo open heart surgery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Normal saline - dexmedetomidine group dexmedetomidine -
- Primary Outcome Measures
Name Time Method The incidence of acute kidney injury 1 week
- Secondary Outcome Measures
Name Time Method Major adverse kidney events (MAKE) 3month, 1 year Cystatin C level postoperative day 1,2,3 and 5 serum cystatin C level (mg/L)
inflammatory mediator(IL-6) level postoperative day 1,2,3 and 5 serum inflammatory mediator (IL-6(pg/mL)
inflammatory mediator(CRP) level postoperative day 1,2,3 and 5 serum inflammatory mediator (CRP(mg/L))
inflammatory mediator(WBC) level postoperative day 1,2,3 and 5 Serum WBC(/microL) level
inflammatory mediator(neutrophil count) level postoperative day 1,2,3 and 5 serum inflammatory mediator (neutrophil count(/microL)) level
serum norepinephrine/epinephrine level(ng/mL) postoperative day 1,2,3 and 5 intraoperative hemodynamics measured by amount of used vasopressors(mL) postoperative day 1,2,3 and 5 intraoperative fluid intake and output 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 postoperative day 1,2,3 and 5 postoperative complications such as development of myocardial infarction, arrhythmia, cerebrovascular accident, wound infection, and mortality.
Trial Locations
- Locations (1)
Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of