Combined Use of Dexmedetomidine and Hydrocortisone to Prevent New Onset Atrial Fibrillation After Coronary Artery Bypass Grafting Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Occurrence of AF
研究概览
简要总结
Atrial fibrillation (AF) occurs in 20% to 40% of patients after Coronary artery bypass grafting (CABG) and is associated with numerous detrimental sequelae. In postoperative period, the patient may be exposed to several proarrhythmogenic factors as increased endogenous catecholamines, inflammatory and oxidative mediators secondary to surgical stress and the systemic response to cardiopulmonary bypass, use of inotropic support. Steroids suppress the release of the above-mentioned inflammatory mediators. Dexmedetomidine is sympatholytic, along with anti-inflammatory properties. so combined use of both drugs may have synergistic effect to prevent post operative AF (POAF)
详细描述
Postoperative atrial fibrillation (POAF) is a common postoperative complication that occurs in 20% to 40% of patients after Coronary artery bypass grafting (CABAG) and is associated with numerous detrimental sequelae.
POAF is an independent predictor of numerous adverse outcomes, including a 2- to 4-fold increased risk of stroke, reoperation for bleeding, infection, renal or respiratory failure, cardiac arrest, cerebral complications, need for permanent pacemaker placement, and a 2-fold increase in all-cause 30-day and 6-month mortality.
Clinical efforts to prevent and manage POAF following cardiac surgery have thus far presented a major challenge and results have been less than optimal. Despite numerous trials examining prophylactic and treatment modalities, POAF incidence following cardiac surgery has not changed over the past several decades.
The pathogenesis of POAF is incompletely understood but likely involves interplay between pre-existing physiological components and local and systemic inflammation. cardiopulmonary bypass and ischemia/reperfusion injury triggers generalized response characterized by leukocyte and complement activation, high levels of C-reactive protein (CRP) complexes, as well high levels of inflammatory mediators. These mediators, such as interleukins-6 and -8, tumor necrosis factors, leukotriene B4, and tissue plasminogen activator, might contribute to many postoperative complications including atrial fibrillation (AF).
Because of the known physiologic effects of steroids to suppress the release of the above-mentioned inflammatory mediators, steroids might have beneficial effects in decreasing postoperative AF, and inhibiting the inflammatory process post cardiopulmonary bypass. Moreover, they decrease capillary wall permeability, preventing migration of inflammatory mediators into the systemic circulation. Also, Corticosteroids decrease the heterogeneity of atrial conduction and reduce inflammation following cardiac surgery, and studies have shown that preoperative prophylactic corticosteroids reduced POAF incidence without an increased rate of postoperative infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for CABG Surgery with cardiopulmonary bypass (CPB) pump
排除标准
- •History of heart block.
- •Patients with preoperative bradycardia (HR < 60 / min)
- •Patients with preoperative hypotension (systolic blood pressure < 90 mmhg)
- •Previous episodes of AF or flutter.
- •Uncontrolled diabetes mellitus requiring insulin treatment with recent hyperglycemia which required hospital treatment.
- •History of peptic ulcer disease.
- •Active systemic bacterial or mycotic infection.
- •Permanent pacemaker.
- •Any documented or suspected supraventricular or ventricular arrhythmias.
- •Urgent or emergency surgery.
- •Planned off-pump surgery.
- •Patient Refusal.
研究组 & 干预措施
Dexmedetomidine + Hydrocortisone group
Patients will receive dexmedetomidine 0.7 ɥg/kg/hr IV infusion before aortic cross-clamping, and will be continued intra-operatively and in ICU till weaning from mechanical ventilation Patients also will also receive Hydrocortisone 100 mg intravenous (IV) before aortic cross-clamping then 100 mg every 8 hours after surgery which will be continued for 48 hours .
干预措施: Dexmedetomidine + Hydrocortisone (Drug)
结局指标
主要结局
Occurrence of AF
时间窗: Up to 7 days Postoperative
The occurrence of an episode of AF postoperatively
次要结局
- Hospital stay(Up to 10 days Postoperative)
- Hyperglycemia(Up to 7 days Postoperative)
- Bradycardia(Up to 2 days Postoperative)
- Wound infection(Up to 2 weeks Postoperative)
- ICU stay(Up to 7 days Postoperative)
- Hypotension(Up to 2 days Postoperative)
研究者
Mohamed Alaaeldin Abdelmoneem Alhadidy
Principal Investigator
Ain Shams University