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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.
EU CTIS ID: 2024-513811-29-00
What this study is testing
The study goal is to evaluate the effect of the early use of levosimendan versus placebo on top of a conventional use of inotrope with regard to a composite endpoint of 30-day mortality and/or ExtraCorporeal Life Support (ECLS) requirement and/or dialysis.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 at inclusion.
- Tissue hypoperfusion: at least 1 sign with in 24 hours 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);
- Patient affiliated to social security plan.
You likely can't join if
- Myocardial sideration after cardiac arrest of non-cardiac etiology;
- 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
See the full eligibility 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 at inclusion.
- Tissue hypoperfusion: at least 1 sign with in 24 hours 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);
- Patient affiliated to social security plan.
- Myocardial sideration after cardiac arrest of non-cardiac etiology;
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.