Microcirculatory and Macrocirculatory Effects of Landiolol in Prevention of Postoperative Atrial Fibrillation: a Randomized Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
研究概览
简要总结
Postoperative atrial fibrillation is a common complication after cardiac surgery and is associated with an elevation of morbidity and mortality. The recommended treatment includes heart rate control with a beta blocker. Landiolol is a new-generation beta-blocker with favourable pharmacologic properties making an interesting drug to treat postoperative atrial fibrillation. However, Landiolol micro and macrocirculatory effects in the setting of atrial fibrillation are yet to describe. The aim of this study is to describe microcirculatory effects of incremental doses of landiolol in postoperative atrial fibrillation compared to a placebo. Our hypothesis is Landiolol will improve microcirculation disorders.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patient underwent conventional cardiac surgery
- •Age > 18 years
- •Writing contentment
排除标准
- •Pre-existing chronic atrial fibrillation
- •Contraindication to beta-blockers
- •Circulatory shock (cardiac index<2.2 L/min and lactate>4mmol/L)
- •Distributive shock (cardiac index>2.2 L/min with norepinephrine dose > 0.3 µg/kg/min to reach mean arterial pressure > 65mmHg).
- •Acute respiratory distress
- •Major bleeding (>200mL/h)
- •Patient already included into an interventional clinical study
- •Pregnancy
- •No social security insurance
- •Patient not able to give consent (curators, patients deprived of public rights)
研究组 & 干预措施
Landiolol group
Landiolol perfusion in incremental doses (range 0.5 to 10 µg/kg/min) over 2 hours
干预措施: Landiolol (Drug)
Placebo group
Placebo perfusion in incremental doses (range 0.03 to 0.6 mL/kg/h) over 2 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Tissular resaturation speed measured by somatic near-infrared spectroscopy (NIRS)
时间窗: at 120 minutes
Tissular resaturation speed is measured after vascular occlusion test. At each time end-point, an occlusion of the arm blood flow with a tourniquet is made. After the nadir of the tissular saturation of the arm is reached the tourniquet is released and the resaturation speed is measured using the NIRS.
次要结局
- cardiac output measured by transthoracic echocardiography(at 120 minutes)
- Microcirculatory mean flow index (MIF) acquired by sublingual microscopy(at 120 minutes)
- proportion of perfused vessels acquired by sublingual microscopy(at 120 minutes)
- heterogeneity of the mean flow index acquired by sublingual microscopy(at 120 minutes)
- systolic arterial pressure(at 120 minutes)
- diastolic arterial pressure(at 120 minutes)
- systemic vascular resistance(at 120 minutes)
- carbon dioxide production (VCO2)(at 120 minutes)
- arterial lactate(at 120 minutes)
- functional capillary density acquired by sublingual microscopy(at 120 minutes)
- Heart rate(at 120 minutes)
- Ejection fraction of the left ventricle (FEVG)(at 120 minutes)
- telediastolic volumes of the left ventricle(at 120 minutes)
- intracardiac filling pressure profiles (E/a, E/Vp, E/e')(at 120 minutes)
- oxygen consumption (V02)(at 120 minutes)
- De Backer score acquired by sublingual microscopy(at 120 minutes)
- telesystolic volumes of the left ventricle(at 120 minutes)
- telediastolic volumes of the right ventricle(at 120 minutes)
- oxygen delivery (DO2),(at 120 minutes)
- telesystolic volumes of the right ventricle(at 120 minutes)
- arterial elastance.(at 120 minutes)
- right ventricle contractility (measured with TAPSE and tricuspid S-wave)(at 120 minutes)