Evaluation of Intraoperative Dexmedetomidine Use on Reducing Inflammatory Response Caused by Cardiopulmonary Bypass in Patients Undergoing Surgical Aortic Valve Replacement
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- interleukin 6
研究概览
简要总结
Aim of this randomized prospective study is to investigate the immunomodulatory effects of dexmedetomidine on outcomes in patients with isolated aortic stenosis after surgical aortic valve replacement.
详细描述
Study will investigate effects of two different doses of dexmedetomidine on concentrations of tumor necrosis factor-α and interleukin-6, on inflammatory parameters (C reactive protein and procalcitonin) and inflammatory complications, renal function, postoperative delirium, anaesthetic and analgetic consumption and compare it to control group. It should provide a better understanding of dexmedetomidine effect on decrease of inflammatory response in patients undergoing cardiac surgery. Short-term infusion of dexmedetomidine could reduce inflammatory postoperative complications, contribute to improvement of perioperative renal function and occurrence of postoperative delirium, supporting recovery and shortening hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomization and study drug preparation by person(s) not involved in patient care, data gathering or outcome evaluation. Group allocation kept in sealed opaque envelope until all data gathered.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •isolated aortic stenosis adult patients with written consent
排除标准
- •BMI <30kg/m2
- •1st, 2nd and 3rd degree AV block
- •bradycardia HR<50/min upon arrival to operating theatre
- •neurological disorders (Parkinson's disease, Myasthenia gravis, multiple sclerosis, brain tumors in anamnesis)
- •recent use of psychoactive drugs
- •alcohol and illicit drug addiction
- •diabetes type I with complications
- •patients who develop hypotension after initiation of dexmedetomidine infusion requiring vasoconstriction therapy
- •patients receiving corticosteroids in perioperative period
- •patients with known allergy to dexmedetomidine
研究组 & 干预措施
Saline
Continuous infusion of saline starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery
干预措施: Placebo (Drug)
Dexmedetomidine 0.5
Continuous infusion of dexmedetomidine in dose 0.5 mcg/kg/min starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery
干预措施: Dexmedetomidine 0.5mcg/kg/h (Drug)
Dexmedetomidine 1
Continuous infusion of dexmedetomidine in dose 1 mcg/kg/min starting after invasive monitoring placement and before initiation of cardiopulmonary bypass (CPB) until the end of surgery
干预措施: Dexmedetomidine 1 mcg/kg/h (Drug)
结局指标
主要结局
interleukin 6
时间窗: 24 hours preoperatively up to 12 hours post CPB
Concentration of IL-6 24 hours preoperatively (T0), before CPB initiation (T1), 5 hours post CPB (T2) and 12 hours post CPB (T3)
tumor necrosis factor alpha
时间窗: 24 hours preoperatively up to 12 hours post CPB
Concentration of TNF-alpha 24 hours preoperatively (T0), before CPB initiation (T1), 5 hours post CPB (T2) and 12 hours post CPB (T3)
次要结局
- Renal function - creatinine(From recruitment date up to 10 days postoperatively)
- Renal function - urea(From recruitment date up to 10 days postoperatively)
- Renal function - diuretic consumption(From recruitment date up to 10 days postoperatively)
- Renal function - GFR(From recruitment date up to 10 days postoperatively)
- Renal function - diuresis(From recruitment date up to 10 days postoperatively)
- Postoperative delirium(From recruitment date up to 30 days postoperatively)
- Inflammatory marker concentration during hospital stay(From recruitment date up to 30 days postoperatively)
- Infection rate(From recruitment date up to 30 days postoperatively)
- Analgesic and anesthetic consumption(From recruitment date up to 10 days postoperatively)
研究者
Zrinka Safaric Oremus
Principal Investigator
University Hospital Dubrava