610
Participants
Start Date
July 3, 2023
Primary Completion Date
February 3, 2027
Study Completion Date
January 3, 2028
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.
RECRUITING
AP-HM, Nord Hospital, Marseille, Marseille
RECRUITING
AP-HM CHU la Timone, Marseille
NOT_YET_RECRUITING
CHU Caen, Caen
RECRUITING
CHU Dijon, Dijon
RECRUITING
CHU Besançon Jean Minjoz Hospital, Besançon
RECRUITING
CHU Nîmes, Carémeau Hospital, Nîmes
RECRUITING
CHU de Toulouse, Toulouse
RECRUITING
CHU Bordeaux - Hopital haut-leveque, Bordeaux
RECRUITING
CHU Montpellier, Arnaud de Villeneuve Hospital, Montpellier
RECRUITING
CHU Montpellier -hôpital Arnaud de Villeneuve, Montpellier
RECRUITING
CHU Rennes, Pontchaillou Hospital, Rennes
RECRUITING
CHU Grenoble, Michallon Hospital, La Tronche
RECRUITING
CHU Grenoble -USIC, La Tronche
RECRUITING
CHU Nantes, Nantes
RECRUITING
CHR Metz-Thionville, Mercy Hospital, Ars-Laquenexy
RECRUITING
CHRU Lille, Cœur Poumon Institute, Lille
RECRUITING
CHRU Strasbourg -Nouvel Hôpital Civil, Strasbourg
RECRUITING
Hospices Civils de Lyon - Louis Pradel Hospital, Bron
RECRUITING
APHP, La Pitié Salpêtrière (medical intensive care unit), Paris
NOT_YET_RECRUITING
CH Henri Duffaut, Avignon, Avignon
RECRUITING
CHU Limoges, Dupuytren Hospital, Limoges
RECRUITING
APHP, Henri Mondor Hospital, Créteil
RECRUITING
CHU Bordeaux, Bordeaux
NOT_YET_RECRUITING
HENRI MONDOR -réanimation, Créteil
RECRUITING
Chu Dijon, Dijon
RECRUITING
Chu Rouen, Rouen
NOT_YET_RECRUITING
HU Strasbourg USIC, Strasbourg
RECRUITING
CHRU Nancy, Vandœuvre-lès-Nancy
Pr Bruno LEVY
OTHER