LANdiolol MIcrocirculatory Effects During Septic chOc
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Rate of decrease in heart rate (HR) on microcirculatory vascular reactivity
研究概览
简要总结
The objectives of this study are to evaluate the effect of continuous intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours ) up to a 15% decrease in Heart Rate (HR) on microcirculatory vascular reactivity vs. usual tachycardia management and evaluate the hemodynamic effects of Landiolol vs. usual management in patients with septic shock.
详细描述
This is a Phase 3, prospective, randomized, open label, evaluation of the efficacy of continuous intravenous Landiolol injection up to a 15% decrease in HR on microcirculatory vascular reactivity vs. usual tachycardia management.
Design:
A monocentric, open-label, randomised, superiority clinical trial
Sample size :
44 patients, 22 in each group
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sinus tachycardia not compensatory, if the doctor considers that the heart rate acceleration should be treated.
- •The study will be carried out in
- •reanimated and stabilized septic shock defined as:
- •Septic shock is tachycardic (HR>100/min) patients with sepsis (suspected infection + 2 SOFA points) according to the latest international definition and the need to receive noradrenaline to maintain an average blood pressure above 65 mmHg
- •Patient supported for at least 6 hours, necessary for diagnostic management and hemodynamic optimization according to international standards and for less than 24 hours to limit confounding factors related to prolonged reanimation (sedation) and empowerment of organ failure in general and vascular in particular. Hemodynamic stabilization will be defined as the absence of increased doses of norepinephrine in the previous two hours to limit the risk of hypotension induced by Landiolol infusion.
- •Age >18 years
- •Patient (or family member) informed consent signature or emergency consent
- •Affiliation to a social security system
排除标准
- •Patients treated with the following bradycardizing drugs:
- •Digitalis
- •Bradycardizing calcium channel blockers
- •Cordarone
- •Other beta-blocker
- •Hypersensitivity to Landiolol or to one of its excipients (Mannitol E421, sodium hydroxide)
- •Sinus disease
- •Cardiogenic shock
- •Decompensated heart failure when considered unrelated to arrhythmia
- •Pregnant or nursing woman,
- •Participation in another interventional research involving the human person or being in the exclusion period following a previous research involving the human person, if applicable
- •Ward or curative patient
- •Moribund patient
- •Estimated life expectancy less than 1 month
研究组 & 干预措施
Landiolol injection
Intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours) up to a 15% decrease in HR on microcirculatory vascular reactivity.
干预措施: Landiolol (Drug)
结局指标
主要结局
Rate of decrease in heart rate (HR) on microcirculatory vascular reactivity
时间窗: 24 hours
The objectives of this study are to evaluate the effect of continuous intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours ) up to a 15% decrease in HR on microcirculatory vascular reactivity vs. usual tachycardia management in patients with septic shock.
次要结局
- Arterial lactate clearance(24 hours)
- Measure of Systemic and endothelial inflammation parameters(24 hours)
- Cardiac flow(24 hours)
- marbling score(24 hours)
- skin recoloration time(24 hours)