Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS (NCT04158674) | Clinical Trial Compass
TerminatedPhase 3
Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS
Stopped: There was insufficient funding to continue the study in good conditions.
France82 participantsStarted 2020-02-24
Plain-language summary
Extracorporeal life support (ECLS) is a circulatory cardio supplementation technique; it therefore makes it possible to compensate for a defective cardiac or cardio-respiratory function. ECLS nevertheless remains a temporary assistance technique pending a potential recovery of cardiac function, or it can be used to direct patients towards a heart transplant or long-term circulatory assistance (Left Ventricular Assist Device (LVAD) or Total Heart). In patients with complete or partial recovery of cardiac and circulatory function, ECLS withdrawal may be considered. Withdrawal from ECLS remains a delicate phase and the risk of failure is high. The mechanism of action of levosimendan, a drug that increases the contractility of the heart, suggests that it would improve the heart-vessel connection and reduce the rate of ECLS withdrawal failure. The effect of levosimendan is maximal 24 to 48 hours after the end of the infusion and has a prolonged period of action.
The objective is to evaluate the efficacy of levosimendan administration (0.2 µg/kg/min over 24 hours) - versus placebo - prior to ECLS removal on the rate of withdrawal failure in patients under ECLS.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adult patient
* patient or person responsible for the patient has given written consent
* patient with acute circulatory heart failure under ECLS
* patient meeting criteria for ECLS withdrawal
* ECLS flow rate at 1.0-1.5l/min and/or ECLS pump rpm ≤ 1500 rpm
* LVEF \> 20% in cardiac ultrasound and aortic ITV \> 10 cm
* VIS score ≤ 10
* Arterial lactates ≤ 2 mmol/l
* Right ventricular outflow tract shortening fraction \> 30%
* Basal diameter at the tricuspid telediastolic ring of the right ventricle \< 35 mm
* Fraction of inspired oxygen combined between ventilator and ECLS \< 80%
* ECLS withdrawl scheduled within 48 hours
* Absence of an initial or progressive infectious episode (no planned introduction of antibiotic therapy within 48 hours prior to inclusion)
Exclusion Criteria:
* Patient with hepatic insufficiency: cytolysis at least 20 times normal
* Drug intoxication and attempted suicide
* Patient with a contraindication to the use of levosimendan:
* hypersensitivity to the active substance or any of the excipients
* severe hypotension and ventricular tachycardia
* significant mechanical obstructions affecting ventricular filling and/or ejection
* severe renal failure (creatinine clearance \< 30 ml/min)
* severe liver failure (TP\<50%)
* history of torsades de pointes
* Patient with a contraindication to the use of CERNEVIT®:
* hypersensitivity to active substances, in particular to vitamin B1 or to one of the excipi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.