Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility: an Open Label Prospective Randomized Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Variation of mortality rate in landiolol group compared to control group
研究概览
简要总结
Several data emphasize the relation between tachycardia (>90/min) and high mortality during septic shock. The investigators previously demonstrated the high mortality associated with hypercontractility, tachycardia and the presence of a left ventricular obstruction. A severe hypovolemia, a hyper adrenergic stimulation or a severe vasoplegia can all explain this relation between tachycardia, hypercontractility and the mortality during septic shock.
Landiolol is another short-term acting beta-blocker with a half-life of 4 minutes without any beta 2 activity or membrane stabilizing effect. The landiolol has been used in critically ill patients to control supraventricular tachycardia but not in this context of tachycardia and septic shock. The investigators hypothesize that landiolol by reducing the heart rate may improve the survival of patients treated for a septic shock and presenting with an hypercontractility state.
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
- •Age ≥ 18 years old
- •Patient admitted for a septic shock (according to the SEPSIS3 definition: sepsis with persisting hypotension (MAP<65mmHg or SAP <90mmHg) requiring vasopressors to maintain MAP>65mmHg and having a serum lactate level >2 mmol/L
- •Patient who received at least 30ml/kg of fluid and absence of fluid responsiveness
- •Left ventricular ejection fraction >65% (visual or Simpson method using echocardiography)
- •Tachycardia >100 bpm in sinus rhythm with a MAP 65mmHg for more than 1 hour
- •Patient receiving invasive mechanical ventilation
- •Patients adapted to the ventilator under sedation and analgesia
- •Written informed consent
- •Patient covered by French national health insurance
排除标准
- •Patients with inclusion criteria already present for more than 36 hours
- •Patient treated with Dobutamine, adrenaline or isoprenaline
- •Patient currently treated with beta blockers (previous home betablocker treatment is not an exclusion criteria)
- •Supra ventricular (atrial fibrillation or flutter) or ventricular arrhythmias
- •Patients with any form of cardiac pacing
- •Sick sinus syndrome
- •Severe atrioventricular (AV) nodal conductance disorders (without pacemaker): 2nd or 3rd degree AV block
- •Known pulmonary hypertension
- •ScVO2 <70%
- •Cardiac arrest
- •Non-treated phaeochromocytoma
- •Acute asthmatic attack
- •Pregnant or breastfeeding woman
- •Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision),
- •Age <18 years
- •Hypersensitivity to the active substance or to any of the excipients
- •Severe bradycardia (less than 50 beats per minute)
- •Cardiogenic shock
- •Severe hypotension
- •Decompensated heart failure when considered not related to the arrhythmia
- •Severe, uncorrectable metabolic acidosis
- •Presence of significant bleeding, or
- •Acute respiratory distress defined by increased oxygen dependency, polypnea > 30 /min, signs of struggle (pulling, thoraco-abdominal sway) if the patient is not intubated and ventilated.
研究组 & 干预措施
Experimental group
2 days with landiolol IV + usual care
干预措施: Landiolol (Drug)
Control group
usual care according to the attending physician and following the guidelines of surviving sepsis campaign.
干预措施: echocardiography (Other)
结局指标
主要结局
Variation of mortality rate in landiolol group compared to control group
时间窗: day 28
次要结局
未报告次要终点