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
- Conditions
- Cardiogenic Shock
- Registration Number
- NCT04020263
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 610
Inclusion Criteria:<br><br>Adult patient = 18 years with cardiogenic shock defined by:<br><br> - Adequate intravascular volume<br><br> - Norepinephrine to maintain MAP at least at 65 mmHg for at least 3 hours and less<br> than 24h. At inclusion the dose must be <1 microgram/kg/min under norepinephrine<br> base or <2 microgram/kg/min under norepinephrine tartrate, OR/AND Dobutamine since<br> at least 3h and less than 24h and at dose = 5 microgram/kg/min at inclusion.<br><br> - Tissue hypoperfusion: at least 1 sign (lactate = 2 mmol/l; mottling, capillary<br> refeel time > 3 seconds, oliguria <500ml/24h or = 20 ml/h during the last 2 hours,<br> ScVO2 = 60% or veno-arterial PCO2 gap = 5 mmHg);<br><br>Exclusion Criteria:<br><br> - Myocardial sideration after cardiac arrest of non-cardiac etiology<br><br> - Immediate or anticipated (within 6 hours) indication of Extra Corporel Life Support<br><br> - Use of VA-ECMO or IMPELLA or LVAD;<br><br> - Cardiogenic choc post cardiac surgery under cardiopulmonary bypass (CPBP) weaned for<br> less or equal of 6 hours.<br><br> - Chronic renal failure requiring hemodialysis<br><br> - Cardiotoxic poisoning<br><br> - Septic cardiomyopathy<br><br> - Previous levosimendan administration within 15 days<br><br> - Cardiac arrest with non-shockable rhythm;<br><br> - No flow time higher > 3 minutes;<br><br> - Cardiac arrest with unknown no flow duration;<br><br> - Total duration of cardiac arrest (no flow plus low flow) > 45 minutes;<br><br> - Cerebral deficit with fixed dilated pupils<br><br> - Patient moribund on the day of enrollment<br><br> - Irreversible neurological pathology<br><br> - Known hypersensitivity to levosimendan or placebo, or one of its excipients<br><br> - Pregnant woman, birthing or breastfeeding mother<br><br> - Minor (not emancipated)<br><br> - Person deprived of liberty for judicial or administrative decision;<br><br> - Adult subject to a legal protection measure (such as guardianship, conservatorship)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of All-cause mortality;Proportion of Extra Corporel Life Support implantation;Proportion of Dialysis
- Secondary Outcome Measures
Name Time Method