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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Hospital, Nancy, France
• Treatments: Simendan

Criteria

Inclusion Criteria:

Adult patient with cardiogenic shock defined by:

• Adequate intravascular volume

• Norepinephrine infusion <1 microgram/kg/min to maintain MAP at least at 65 mmHg for at least 3 hours and less than 12h or dobutamine ≥ 5 microgram/kg/min since at least 3h and less than 12h

• Tissue hypoperfusion: at least 2 signs (lactate ≥ 2 mmol/l, mottling, oliguria, ScVO2 ≤ 60% or veno-arterial PCO2 gap ≥ 5 mmHg)

• Clinical pulmonary congestion or elevated natriuretic peptides or echocardiographic sign of elevated left ventricular pressure or elevated right atrial pressure.

Exclusion Criteria:

• Myocardial sideration after cardiac arrest of non-cardiac etiology

• Immediate or anticipated (within 6 hours) indication of Extra Corporel Life Support

• Extra Corporel Life Support (Extracorporeal Membrane Oxygenation (ECMO) or Impella)

• Chronic renal failure requiring hemodialysis

• Cardiotoxic poisoning

• Septic cardiomyopathy

• Previous levosimendan administration within 15 days

• Cardiac arrest resuscitation >30 minutes

• Cerebral deficit with fixed dilated pupils

• Patient moribund on the day of randomization

• Irreversible neurological pathology

• Known hypersensitivity to levosimendan or placebo, or one of its excipients

• Woman of childbearing age without effective contraception

• Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code:

• Pregnant, parturient or breastfeeding woman

• Person deprived of liberty for judicial or administrative decision

• Person under psychiatric care

• Minor person (non-emancipated)

• Adult person under legal protection (any form of public guardianship)