- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04158674
Levosimendans intresse för att minska avvänjningsmisslyckanden av extrakorporalt livstöd - ECLS (Weanilevo)
Intresse av Levosimendan för att minska avvänjningsmisslyckanden av ExtraCorporeal Life Support - ECLS. Randomiserad, kontrollerad, multicenter, dubbelblind, multicenter klinisk prövning
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
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Dijon, Frankrike, 21079
- CHU Dijon Bourgogne
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
adult patient
-
patient or person responsible for the patient has given written consent
-
patient with acute circulatory heart failure under ECLS
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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%
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ECLS withdrawl scheduled within 48 hours
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Absence of an initial or progressive infectious episode (no planned introduction of antibiotic therapy within 48 hours prior to inclusion)
Exclusion Criteria:
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Patient with hepatic insufficiency: cytolysis at least 20 times normal
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Drug intoxication and attempted suicide
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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
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Patient with a contraindication to the use of CERNEVIT®:
- hypersensitivity to active substances, in particular to vitamin B1 or to one of the excipients or to soy protein products or to peanut protein products
- hypervitaminosis to any vitamin contained in this formulation
- severe hypercalcemia, hyper calciuria, tumour, bone metastasis, primary hyperparathyroidism, granulomatosis
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patient not affiliated to or not benefiting from national health insurance
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patient subject to legal protection (curatorship, guardianship)
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patient subject to limited judicial protection
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pregnant, parturient or breastfeeding woman
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Sham Comparator: Placebo
|
mixture of 12 vitamins The dilution of the treatment is done in a 500ml bag of 5% Glucose The product is administered as a continuous infusion for 24 hours at an initial rate of 0.2 µg/kg/min |
|
Experimentell: Levosimendan
|
Levosimendan 2.5mg/ml, solution to be diluted for infusion Dilution in a 500ml bag of 5% Glucose The product is administered as a continuous infusion for 24 hours at an initial rate of 0.2 µg/kg/min |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
ECLS withdrawal failure
Tidsram: 7 days after ECLS removal
|
Withdrawal failure is defined as the absence of ECLS discontinuation within 48 hours of randomization or the use of temporary circulatory assistance such as ECLS, Impella® pump or intra-aortic balloon pump (IABP) or death |
7 days after ECLS removal
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- Ellouze O, Soudry Faure A, Radhouani M, Abou-Arab O, Besnier E, Moussa M, Cransac A, Ksiazek E, Fischer MO, Mertes PM, Bouhemad B, Guinot PG. Levosimendan in venoarterial ECMO weaning. Rational and design of a randomized double blind multicentre trial. ESC Heart Fail. 2021 Aug;8(4):3339-3347. doi: 10.1002/ehf2.13427. Epub 2021 Jun 18.
- Guinot PG, Berthoud V, Soudry-Faure A, Abou-Arab O, Mertes PM, Fischer MO, Moussa M, Ellouze O, Nguyen M, Bouhemad B; for WEANILEVO trial group. Short- and Long-term Efficacy and Safety of Levosimendan in Veno-arterial Extracorporeal Membrane Oxygenation Weaning: The WEANILEVO Randomized Double-Blind Multicenter Trial. Anesthesiology. 2026 Jul 20. doi: 10.1097/ALN.0000000000006143. Online ahead of print.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ELLOUZE_ORION_2018
Läkemedels- och apparatinformation, studiedokument
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