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.

Phase 1

• Conditions: Cardiogenic Shock; MedDRA version: 20.0Level: PTClassification code: 10007625Term: Cardiogenic shock Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2024-513811-29-00
• Lead Sponsor: CHRU De Nancy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-09
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 610

Inclusion Criteria

Adult patient = 18 years with cardiogenic shock, 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 and at dose = 5 microgram/kg/min at inclusion., Tissue hypoperfusion: at least 1 sign (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);, Patient affiliated to social security plan.

Exclusion Criteria

Myocardial sideration after cardiac arrest of non-cardiac etiology;, 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, Person deprived of liberty for judicial or administrative decision, Minor (not emancipated), Immediate or anticipated (within 6 hours) indication of ECLS;, Adult subject to a legal protection measure (such as guardianship, conservatorship), Use of VA-ECMO or IMPELLA or LVAD, Cardiogenic choc post cardiac surgery under cardiopulmonary bypass (CPBP) weaned for less or equal of 6 hours., Chronic renal failure requiring hemodialysis;, Cardiotoxic poisoning, Septic cardiomyopathy, Previous levosimendan administration within 15 days, Cardiac arrest with non-shockable rhythm

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified