2024-513811-29-00招募中3 期
Effect of early use of levosimendan versus placebo on top of a conventional strategy of inotrope use on a combined morbidity-mortality endpoint in patients with cardiogenic shock. LevoHeartShock
CHRU De Nancy21 个研究点 分布在 1 个国家目标入组 610 人开始时间: 2024年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 610
- 试验地点
- 21
- 主要终点
- All-cause mortality and/or ECLS and/or dialysis at day 30 following randomization.
研究概览
简要总结
The study goal is to evaluate the effect of the early use of levosimendan versus placebo on top of a conventional use of inotrope with regard to a composite endpoint of 30-day mortality and/or ExtraCorporeal Life Support (ECLS) requirement and/or dialysis.
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomized period
- 盲法
- Double (Analyst, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adult patient ≥ 18 years with cardiogenic shock
- •Adequate intravascular volume
- •Norepinephrine to maintain MAP at least at 65 mmHg for at least 3 hours and less than 24h. At inclusion the dose must be <1 microgram/kg/min under norepinephrine base or <2 microgram/kg/min under norepinephrine tartrate, OR/AND Dobutamine since at least 3h and less than 24h at inclusion.
- •Tissue hypoperfusion: at least 1 sign with in 24 hours prior to inclusion (lactate ≥ 2 mmol/l; mottling, capillary refeel time > 3 seconds, oliguria <500ml/24h or ≤ 20 ml/h during the last 2 hours, ScVO2 ≤ 60% or veno-arterial PCO2 gap ≥ 5 mmHg);
- •Patient affiliated to social security plan.
排除标准
- •Myocardial sideration after cardiac arrest of non-cardiac etiology;
- •Person deprived of liberty for judicial or administrative decision
- •Minor (not emancipated)
- •Immediate or anticipated (within 6 hours) indication of ECLS;
- •Adult subject to a legal protection measure (such as guardianship, conservatorship)
- •Use of VA-ECMO or IMPELLA or LVAD
- •Chronic renal failure requiring hemodialysis;
- •Cardiotoxic poisoning
- •Septic cardiomyopathy
- •Previous levosimendan administration within 15 days
- •Cardiac arrest with non-shockable rhythm
- •No flow time higher > 3 minutes
- •Cardiac arrest with unknown no flow duration
- •Total duration of cardiac arrest (no flow plus low flow) > 45 minutes
- •Cerebral deficit with fixed dilated pupils
- •Patient moribund on the day of enrollment
- •Irreversible neurological pathology
- •Known hypersensitivity to levosimendan or placebo, or one of its excipients;
- •Pregnant woman, birthing or breastfeeding mother
结局指标
主要结局
All-cause mortality and/or ECLS and/or dialysis at day 30 following randomization.
All-cause mortality and/or ECLS and/or dialysis at day 30 following randomization.
次要结局
- Prioritized composite endpoint at days 90 with the following priority order: 1/ time to death, 2/ escalation to permanent left ventricular assist device or cardiac transplantation, 3/ dialysis, 4/ ECLS requirement, 5/ number of cardiovascular events (stroke, recurrent myocardial infarction, urgent coronary revascularization, re-hospitalization for heart failure).
- Major adverse cardiovascular events: death, ECLS requirement, dialysis, cardiac transplantation, escalation to permanent left ventricular assist device, major cardiovascular events (stroke, recurrent myocardial infarction, urgent coronary revascularization, re-hospitalization for heart failure) on days 90
- Composite endpoint of all-cause mortality and/or ECLS requirement and/or dialysis on day 90;
- Number of dobutamine free days between randomization and D30
- Number of vasopressors free days between randomization and D30;
- Number of ventilatory free days between randomization and D30
- Number of renal replacement free days between randomization and D 90
- Lactate clearance from randomization to D7
- Duration of ICU stay and hospitalization
- Composite endpoint of all-cause mortality and/or ECLS requirement and/or dialysis on days 7, 60, and 180 days and 12 months following randomization
- Number of renal replacement free days between randomization and D 30, 60, 180 and at 12 months
- Major adverse cardiovascular events: death, ECLS requirement, dialysis, cardiac transplantation, escalation to permanent left ventricular assist device, major cardiovascular events (stroke, recurrent myocardial infarction, urgent coronary revascularization, re-hospitalization for heart failure) on days 180 and at 12 months;
- Occurrence of arrhythmias requiring therapy with anti-arrhythmic drugs or electric cardioversion (including atrial fibrillation, ventricular tachycardia, ventricular fibrillation, torsade de pointe) from randomization to ICU or CCU discharge.
- Changes in biomarkers between randomization and ICU/CCU discharge
- For objectives B2 and B3 the primary outcome will be considered
研究者
Pr Bruno LEVY
Scientific
CHRU De Nancy
研究点 (21)
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