Status:
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
Lead Sponsor:
Pr Bruno LEVY
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Adult patient ≥ 18 years with cardiogenic shock defined by:
- 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
- Myocardial sideration after cardiac arrest of non-cardiac etiology
- 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)
Key Trial Info
Start Date :
July 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 3 2028
Estimated Enrollment :
610 Patients enrolled
Trial Details
Trial ID
NCT04020263
Start Date
July 3 2023
End Date
January 3 2028
Last Update
August 5 2025
Active Locations (28)
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1
CHRU Strasbourg -Nouvel Hôpital Civil
Strasbourg, Bas-Rhin, France, 67091
2
AP-HM, Nord Hospital, Marseille
Marseille, Bouches du Rhône, France, 13015
3
CHU Caen
Caen, Calvados, France, 14000
4
CHU Dijon
Dijon, Côte d'Or, France, 21000