Trial intelligence / Profile preview

Levosimendan Pretreatment in CABG with Low EF

NCT02184819Phase 3

Key facts

Status: Completed
Start: Jun 2013
Primary completion: Jun 2015
Countries: 1
Sponsor: Assistance publique - Hôpitaux de Paris
Modality: Small Molecules

Drugs: levosimendan
Conditions: low cardiac output syndrome (LCOS)

Overview

Phase 3, randomised, double-blind trial in low cardiac output syndrome (LCOS) comparing Levosimendan with Placebo (2 arms). Primary endpoint: Confirmed Low Cardiac Output Syndrome at 28 days. Started Jun 2013; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Levosimendan
Levosimendan 0.1 mcg/kg/min for 24 hours
Placebo
Placebo infusion for 24 hours

Who it enrols

Adult patients scheduled for CABG with CPB and ejection fraction less than 40%, excluding those with renal or liver failure, severe hypotension, or tachycardia.

Endpoints

Primary

Confirmed Low Cardiac Output Syndrome28 days

Secondary

Mortality180 days
Need for Inotropic Agents24 hours post-infusion
Renal Replacement Therapy28 days
Ventilator-Free Days28 days
Out-of-ICU Days28 days

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