2024-518251-31-00招募中3 期
Comparison of Landiolol versus standard of care for prevention of mortality in patients hospitalized for a septic shock with hypercontractlity: 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
- 34
- 主要终点
- mortality at day 28
研究概览
简要总结
is to demonstrate that the reduction of heart rate using the landiolol may improve the mortality of septic shock patients with tachycardia and hypercontractility in comparison to control group at day 28
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years old
- •Patient with a septic shock (according to the SEPSIS3 definition: sepsis with persisting hypotension (MAP<65mmHg or SAP <90mmHg) requiring vasopressors to maintain MAP>65mmHg with at least one lactate dosage >2 mmol/L during the current shock episode.
- •patient who received between 10 and 30ml/kg of fluid and absence of fluid responsiveness
- •Left ventricular ejection fraction > 60 % (visual or Simpson method using echocardiography)
- •Tachycardia >95 bpm with a MAP 65mmHg for more than 1 hour
- •Patient either in spontaneous ventilation or intubated and ventilated
排除标准
- •Patients with inclusion criteria already present for more than 36 hours
- •Non-treated phaeochromocytoma
- •Acute asthmatic attack
- •Hypersensitivity to the active substance or to any of the excipients
- •Severe bradycardia (less than 50 beats per minute)
- •Cardiogenic shock
- •Severe hypotension uncontrolled
- •Decompensated heart failure when considered not related to the errhythmia
- •Severe, uncorrectable metabolic acidosis
- •Presence of significant bleeding, or spontaneously ventilated patient in respiratory distress requiring immediate intubation
- •Patient treated with Dobutamine, adrenaline or isoprenaline
- •Patient currently treated with beta blockers (previous home betablocker treatment is not an exclusion criteria)
- •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
- •in- or out-of-hospital cardiac arrest without signs of early recovery
结局指标
主要结局
mortality at day 28
mortality at day 28
次要结局
- - Number of patients that achieved a reduction of heart rate equal or higher to 20% of the initial HR with landiolol
- - Number of days receiving catecholamines
- - Number of days receiving mechanical ventilation
- - Length of stay in ICU and hospital
- - SOFA score at inclusion and day 1, 2, 3, 7, 14 and 28 following the inclusion
- - Number of patients developing atrial fibrillation of flutter during the first three days
- - Hospital mortality
- - Number of episodes of bradycardia (<50 bpm) or LVEF < 45% or MAP <65mmHg requiring an increase of Norepinephrine > 40% during the entire period of treatment with the landiolol
- - Unexpected cardiac arrest
研究者
Coordinating investigator
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (34)
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