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
NCT ID: NCT04020263
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
610 participants
INTERVENTIONAL
2023-07-03
2028-01-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Levosimendan
Experimental group: patients with cardiogenic shock treated with levosimendan in addition to the conventional strategy.
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
Control group: Patients with cardiogenic shock treated with placebo (Cernevit/Soluvit) in addition to the conventional strategy.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Pr Bruno LEVY
OTHER
Responsible Party
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Pr Bruno LEVY
Investigator coordonnator
Principal Investigators
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Clément DELMAS, Dr
Role: STUDY_CHAIR
University Hospital, Toulouse
Nicolas GIRERD, Pr
Role: STUDY_CHAIR
CHRU Nancy
Patrick ROSSIGNOL, Pr
Role: STUDY_CHAIR
CHRU Nancy
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Ferhat MEZIANI, MD-PhD
Role: primary
Laurent Bonello, MD
Role: primary
Katrien Blanchart, MD
Role: primary
Jean-Pierre Quenot, MD-PhD
Role: primary
Hadrien WINISZEWSKI, MD
Role: primary
Benoît Lattuca, MD
Role: primary
Edouard Gerbaud, MD
Role: primary
Clément Delmas, MD
Role: primary
Philippe Vignon, MD
Role: primary
François Roubille, MD
Role: primary
Abdelkader BAKHTI, MD
Role: primary
Joanna Bougnaud, MD
Role: primary
Julien Plessis, MD
Role: primary
Guillaume Louis, MD
Role: primary
Gilles LEMESLE, MD-PhD
Role: primary
Alain Combes, MD
Role: primary
Stéphane Andrieu, MD
Role: primary
Alexandre OUTARRA, MD-PhD
Role: primary
Pierre Grégoire GUINOT, MD-PhD
Role: primary
Nicolas PILIERO, MD
Role: primary
Florent ARREGLE, MD
Role: primary
Philippe GAUDARD, MD-PhD
Role: primary
Emmanuel BESNIER, MD-PhD
Role: primary
Bruno Lévy, Prof
Role: primary
Other Identifiers
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2024-513811-29-00
Identifier Type: CTIS
Identifier Source: secondary_id
2024-513811-29-00
Identifier Type: -
Identifier Source: org_study_id
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