Effect of Dexmedetomidine on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- The incidence of acute kidney injury
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with infective endocarditis
- •patients who are scheduled to undergo open heart surgery
排除标准
- •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
研究组 & 干预措施
Control group
干预措施: Normal saline (Drug)
dexmedetomidine group
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
The incidence of acute kidney injury
时间窗: 1 week
次要结局
- Cystatin C level(postoperative day 1,2,3 and 5)
- inflammatory mediator(IL-6) level(postoperative day 1,2,3 and 5)
- inflammatory mediator(CRP) level(postoperative day 1,2,3 and 5)
- inflammatory mediator(WBC) level(postoperative day 1,2,3 and 5)
- inflammatory mediator(neutrophil count) level(postoperative day 1,2,3 and 5)
- 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)
- postoperative complications(postoperative day 1,2,3 and 5)
- Major adverse kidney events (MAKE)(3month, 1 year)