Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- The duration of treatment with norepinephrine.
研究概览
简要总结
After cardiac surgery, vasoplegic syndrome is a hemodynamic state characterized by profound hypotension associated with a decrease in systemic vascular resistance. The care of this disease is based on the intravenous administration of a vasopressor, usually norepinephrine. During the recovery phase, weaning of norepinephrine, is an important step in which any lack of preload (blood volume) initial or secondary can be, and increase tissue malperfusion.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patient ≥ 18 years
- •Patient operated a cardiac surgery for myocardial revascularization (CABG surgery) or surgical correction of valvular or combined surgery (CABG and valve disease) or surgery the ascending aorta and cardiac surgery with vasoplegic syndrome treated by norepinephrine
- •Signed consent
- •Affiliation to social assurance
排除标准
- •Permanent atrial fibrillation
- •Treatment with dobutamine and/or epinephrine
- •Pregnant woman
- •Patient under guardianship or private public law
- •Internal pacemaker
- •Hypothermia
- •Patient refusal
研究组 & 干预措施
administration of norepinephrine by dynamic elastance
The norepinephrine weaning strategy is based on an index that reflects the vasomotor tone: dynamic arterial elastance
干预措施: Norepinephrine (Drug)
control administration of norepinephrine
The usual procedure of withdrawal norepinephrine is based on hemodynamic parameters (blood pressure), clinical (cutaneous perfusion, mottling, hourly diuresis) and biological (SVO2, arterial lactate).
干预措施: Norepinephrine (Drug)
结局指标
主要结局
The duration of treatment with norepinephrine.
时间窗: Day 28
Mean duration time of norepinephrine administration calculated in hours
次要结局
- ICU duration of stay in day(Day 28)
- Total urine output in ml during the study period(Day 28)
- Total of crystalloid an colloid infused during the study period (ml)(Day 28)
- the rate of arterial lactate at the end of norepinephrine administration(Day 28)
- Incidence of postoperative atrial arrhythmias (Ac/Fa, Ventricular tachycardia, Ventricular flutter, Ventricular fibrillation) during the study period(Day 28)
- SOFA score(Day 28)
- The total dose of norepinephrine infused during the study period(Day 28)