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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
Sponsor: Pr Bruno LEVY
Summary
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 dobutamine, would accelerate the resolution of signs of low cardiac output and facilitate myocardial recovery.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
610
Start Date
2023-07-03
Completion Date
2028-01-03
Last Updated
2025-08-05
Healthy Volunteers
No
Conditions
Interventions
Levosimendan 2.5 MG/ML Injectable Solution
Levosimendan will be diluted with Glucose G5%. The reconstitution of levosimendan will be performed, as close as possible to the start of the infusion. A continuous infusion of levosimendan will be administered over 24 h without bolus, started at a rate of 0.1 μg per kilogram of body weight per minute and, in both the persistence of hypoperfusion signs and in the absence of rate-limiting side effects, will be increased after 2 to 4 hours to a maximum of 0.2 μg per kilogram per minute for a further 20 to 22 hours.
Placebo
Placebo will be diluted with Glucose G5%. The reconstitution of Placebo will be performed, as close as possible to the start of the infusion. A continuous infusion of Placebo will be administered over 24 h without bolus, started at a rate of 0.1 μg per kilogram of body weight per minute and, in both the persistence of hypoperfusion signs and in the absence of rate-limiting side effects, will be increased after 2 to 4 hours to a maximum of 0.2 μg per kilogram per minute for a further 20 to 22 hours.
Locations (28)
CHRU Strasbourg -Nouvel Hôpital Civil
Strasbourg, Bas-Rhin, France
AP-HM, Nord Hospital, Marseille
Marseille, Bouches du Rhône, France
CHU Caen
Caen, Calvados, France
CHU Dijon
Dijon, Côte d'Or, France
CHU Besançon Jean Minjoz Hospital
Besançon, Doubs, France
CHU Nîmes, Carémeau Hospital
Nîmes, Gard, France
CHU Bordeaux - Hopital haut-leveque
Bordeaux, Gironde, France
CHU de Toulouse
Toulouse, Haute-Garonne, France
CHU Limoges, Dupuytren Hospital
Limoges, Haute-Vienne, France
CHU Montpellier, Arnaud de Villeneuve Hospital
Montpellier, Hérault, France
CHU Rennes, Pontchaillou Hospital
Rennes, Ille et Vilaine, France
CHU Grenoble, Michallon Hospital
La Tronche, Isère, France
CHU Nantes
Nantes, Loire-Atlantique, France
CHR Metz-Thionville, Mercy Hospital
Ars-Laquenexy, Moselle, France
CHRU Lille, Cœur Poumon Institute
Lille, Nord, France
APHP, La Pitié Salpêtrière (medical intensive care unit)
Paris, Paris, France
Hospices Civils de Lyon - Louis Pradel Hospital
Bron, Rhône, France
APHP, Henri Mondor Hospital
Créteil, Val de Marne, France
CH Henri Duffaut, Avignon
Avignon, Vaucluse, France
CHU Bordeaux
Bordeaux, France
HENRI MONDOR -réanimation
Créteil, France
Chu Dijon
Dijon, France
CHU Grenoble -USIC
La Tronche, France
AP-HM CHU la Timone
Marseille, France
CHU Montpellier -hôpital Arnaud de Villeneuve
Montpellier, France
Chu Rouen
Rouen, France
HU Strasbourg USIC
Strasbourg, France
CHRU Nancy
Vandœuvre-lès-Nancy, France