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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

RecruitingPhase 3Ages 18 Years - anyAllPr Bruno LEVY
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In plain words

What the trial is, and whether it could suit you

Cardiogenic shock (CS) mortality remains high (40%). Despite their frequent use, few clinical outcome data are available to guide the initial selection of vasoactive drug therapies in patients with CS. Based on experts' opinions, the combination of norepinephrine-dobutamine is generally recommended as a first line strategy. Inotropic agents increase myocardial contractility, thereby increasing cardiac output. Dobutamine is commonly recommended to be the inotropic agent of choice and levosimendan is generally used following dobutamine failure. It may represent an ideal agent in cardiogenic shock, since it improves myocardial contractility without increasing cAMP or calcium concentration. At present, there are no convincing data to support a specific inotropic agent in patients with cardiogenic shock. Our hypothesis is that the early use of levosimendan, by enabling the discontinuation of

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📋 Eligibility rules (as published)
Inclusion Criteria: Adult patient ≥ 18 years with cardiogenic shock defined by: * 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 within 24h 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); Exclusion Criteria: * Myocardial sideration after cardiac arrest of non-cardiac etiology * Immediate or anticipated (within 6 hours) indication of Extra Corporel Life Support * 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 * Minor (not emancipated) * Person deprived of liberty for judicial or administrative decision; * Adult subject to a legal protection measure (such as guardianship, conservatorship)
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What it tests

  • Levosimendan 2.5 MG/ML Injectable Solution
  • Placebo
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Where

28 sites
CHRU Strasbourg -Nouvel Hôpital Civil
Strasbourg, France
AP-HM, Nord Hospital, Marseille
Marseille, France
CHU Caen
Caen, France
CHU Dijon
Dijon, France
CHU Besançon Jean Minjoz Hospital
Besançon, France
CHU Nîmes, Carémeau Hospital
Nîmes, France
CHU Bordeaux - Hopital haut-leveque
Bordeaux, France
CHU de Toulouse
Toulouse, France

…and 20 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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