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RECRUITING
NCT04020263
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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