Actively Recruiting
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
Led by Pr Bruno LEVY · Updated on 2025-08-05
610
Participants Needed
28
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient 18 years or older with cardiogenic shock
- Adequate intravascular volume
- Receiving norepinephrine to maintain mean arterial pressure at least 65 mmHg for 3 to less than 24 hours with dose less than 1 microgram/kg/min (norepinephrine base) or less than 2 microgram/kg/min (norepinephrine tartrate), OR/AND receiving dobutamine for at least 3 hours and less than 24 hours
- Evidence of tissue hypoperfusion within 24 hours before inclusion, shown by at least one sign: lactate 2 mmol/l or higher, mottling, capillary refill time over 3 seconds, low urine output less than 500 ml/24h or 20 ml/h in last 2 hours, ScVO2 60% or less, or veno-arterial PCO2 gap 5 mmHg or higher
You will not qualify if you...
- Myocardial stunning after cardiac arrest from non-cardiac cause
- Immediate or expected need for extracorporeal life support within 6 hours
- Use of VA-ECMO, IMPELLA, or LVAD devices
- Chronic kidney failure requiring hemodialysis
- Poisoning affecting heart function
- Septic cardiomyopathy
- Received levosimendan within past 15 days
- Cardiac arrest with non-shockable rhythm
- No flow time exceeding 3 minutes or unknown duration
- Total cardiac arrest time over 45 minutes
- Fixed dilated pupils indicating brain damage
- Moribund state on enrollment day
- Irreversible neurological disease
- Known allergy to levosimendan, placebo, or their components
- Pregnant, birthing, or breastfeeding women
- Minors who are not emancipated
- Persons deprived of liberty by judicial or administrative decision
- Adults under legal protection measures such as guardianship or conservatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
CHRU Strasbourg -Nouvel Hôpital Civil
Strasbourg, Bas-Rhin, France, 67091
Actively Recruiting
2
AP-HM, Nord Hospital, Marseille
Marseille, Bouches du Rhône, France, 13015
Actively Recruiting
3
CHU Caen
Caen, Calvados, France, 14000
Not Yet Recruiting
4
CHU Dijon
Dijon, Côte d'Or, France, 21000
Actively Recruiting
5
CHU Besançon Jean Minjoz Hospital
Besançon, Doubs, France, 25000
Actively Recruiting
6
CHU Nîmes, Carémeau Hospital
Nîmes, Gard, France, 30029
Actively Recruiting
7
CHU Bordeaux - Hopital haut-leveque
Bordeaux, Gironde, France, 33600
Actively Recruiting
8
CHU de Toulouse
Toulouse, Haute-Garonne, France, 31059
Actively Recruiting
9
CHU Limoges, Dupuytren Hospital
Limoges, Haute-Vienne, France, 87000
Actively Recruiting
10
CHU Montpellier, Arnaud de Villeneuve Hospital
Montpellier, Hérault, France, 34090
Actively Recruiting
11
CHU Rennes, Pontchaillou Hospital
Rennes, Ille et Vilaine, France, 35000
Actively Recruiting
12
CHU Grenoble, Michallon Hospital
La Tronche, Isère, France, 38043
Actively Recruiting
13
CHU Nantes
Nantes, Loire-Atlantique, France, 44000
Actively Recruiting
14
CHR Metz-Thionville, Mercy Hospital
Ars-Laquenexy, Moselle, France, 57245
Actively Recruiting
15
CHRU Lille, Cœur Poumon Institute
Lille, Nord, France, 59000
Actively Recruiting
16
APHP, La Pitié Salpêtrière (medical intensive care unit)
Paris, Paris, France, 75013
Actively Recruiting
17
Hospices Civils de Lyon - Louis Pradel Hospital
Bron, Rhône, France, 69500
Actively Recruiting
18
APHP, Henri Mondor Hospital
Créteil, Val de Marne, France, 94010
Actively Recruiting
19
CH Henri Duffaut, Avignon
Avignon, Vaucluse, France, 84000
Not Yet Recruiting
20
CHU Bordeaux
Bordeaux, France
Actively Recruiting
21
HENRI MONDOR -réanimation
Créteil, France
Not Yet Recruiting
22
Chu Dijon
Dijon, France
Actively Recruiting
23
CHU Grenoble -USIC
La Tronche, France, 38700
Actively Recruiting
24
AP-HM CHU la Timone
Marseille, France, 13385
Actively Recruiting
25
CHU Montpellier -hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Actively Recruiting
26
Chu Rouen
Rouen, France
Actively Recruiting
27
HU Strasbourg USIC
Strasbourg, France
Not Yet Recruiting
28
CHRU Nancy
Vandœuvre-lès-Nancy, France
Actively Recruiting
Research Team
B
Bruno LEVY, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here