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TERMINATED
NCT04158674
PHASE3

Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS

Sponsor: Centre Hospitalier Universitaire Dijon

View on ClinicalTrials.gov

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.

Official title: Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS. Randomized, Controlled, Multicenter, Double-blind, Multicenter Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2020-02-24

Completion Date

2023-10-11

Last Updated

2026-09-28

Healthy Volunteers

No

Interventions

DRUG

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

DRUG

Cernevit

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

Locations (1)

CHU Dijon Bourgogne

Dijon, France