EUCTR2019-001563-74-FR进行中（未招募）1 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 Study. - LevoHearShock
CHRU de Nancy0 个研究点目标入组 610 人开始时间: 2020年6月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 610
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult patient = 18 years with cardiogenic shock defined by :
- •-Adequate intravascular volume
- •-Norepinephrine infusion <1 microgram/kg/min to maintain MAP at least at 65 mmHg for at least 3 hours and less than 24h or dobutamine = 5 microgram/kg/min since at least 3h and less than 24h
- •-Tissue hypoperfusion: at least 2 signs (lactate = 2 mmol/l, mottling, oliguria <500ml/24h, ScVO2 = 60% or veno-arterial PCO2 gap = 5 mmHg)
- •-Clinical pulmonary congestion and/or echocardiographic sign of elevated left ventricular pressure and/or elevated right atrial pressure.
- •Patient affiliated to social security plan.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 427
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 183
排除标准
- •-Myocardial sideration after cardiac arrest of non-cardiac etiology
- •-Immediate or anticipated (within 6 hours) indication of ECLS
- •-ECLS (ECMO or Impella)
- •-Chronic renal failure requiring hemodialysis
- •-Cardiotoxic poisoning
- •-Septic cardiomyopathy
- •-Previous levosimendan administration within 15 days
- •-Cardiac arrest resuscitation >30 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
- •-Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the french Public Health Code:
- •oPregnant, parturient or breastfeeding woman
- •oPerson deprived of liberty for judicial or administrative decision
- •oPerson under psychiatric care
- •oMinor person (non-emancipated)
- •oAdult person under legal protection (any form of public guardianship)
研究者
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