Using levosimendan to treat cardiogenic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of early administration of levosimendan compared to a placebo in patients experiencing cardiogenic shock. The study aims to determine if levosimendan can improve outcomes by enhancing myocardial contractility without the adverse effects associated with traditional inotropic therapies. Participants will be adults with cardiogenic shock who have been stabilized with norepinephrine and/or dobutamine. The trial will assess the impact of levosimendan on morbidity and mortality rates in this high-risk population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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 Criteria:

* 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)

Where it's running

• CHRU Strasbourg -Nouvel Hôpital Civil
  Strasbourg, Bas-Rhin, France Recruiting
• AP-HM, Nord Hospital, Marseille
  Marseille, Bouches du Rhône, France Recruiting
• CHU Dijon
  Dijon, Côte d'Or, France Recruiting
• CHU Besançon Jean Minjoz Hospital
  Besançon, Doubs, France Recruiting
• CHU Nîmes, Carémeau Hospital
  Nîmes, Gard, France Recruiting
• CHU Bordeaux - Hopital haut-leveque
  Bordeaux, Gironde, France Recruiting

Study contacts

• Study coordinator: Bruno LEVY, Pr
• Email: b.levy@chru-nancy.fr
• Phone: +33 3 83 15 40 84

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.