Ignite Creation Date:
2024-05-06 @ 3:02 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02184819
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2013-10-23
Brief Title:
Preoperative Levosimendan in CABG Patients With Poor LV Function
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Effects of Levosimendan Pretreatment in Patients With Low Ejection Fraction 40 or Less Undergoing CABG a Randomised Double Blind Multicenter Trial
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LICORN
Brief Summary:
The investigators want to test the hypothesis that an infusion of levosimendan started prior to CABG surgery can reduce incidence and severity of low cardiac output syndrome in patients with poor LV function EF 40 or less
Detailed Description:
Background Patients with an ejection fraction of less than 40 are at high risk of developing postoperative low cardiac output syndrome LCOS Despite the use of potent inotropic agents or even ventricular mechanical assist devices the mortality rate of such patients remains very high from 17 to 38 Their hospital stay is also prolonged and the cost of care for this population is increased Two studies have suggested that post-operative administration of levosimendan could reduce hospital length of stay and long term Day180 mortality in patients with LCOS In addition a few studies have also suggested that pre-operative infusion of levosimendan pre-conditioning could reduce the use of other inotropes and mechanical assist devices in patients at high risk of developing LCOS Unfortunately the data supporting the beneficial effects of levosimendan in high risk cardiac surgery patients is very limited Main goal To evaluate the efficacy of a pre-operative infusion of levosimendan in high risk patients EF less than 40 undergoing cardiac surgery CABG or combined surgery CABG and valve replacement to improve outcome Secondary goals To evaluate 1 the clinical safety of a pre-operative infusion of levosimendan 2 the costs of care in the levosimendan and control groups Experimental setup Prospective multicenter randomized versus placebo double-blind trial Treatment modalities levosimendan will be administered by the intravenous route according to a continuous infusion of 01mcgkgmin over 24 hours Levosimendan infusion 01mcgkgmin will be started immediately after induction of anaesthesia The delay between infusion start and skin incision can be estimated between 30 to 60 min The investigators decided to skip the bolus infusion that is frequently associated with systemic hypotension which may result in serious adverse events and protocol exclusion Study duration and patient follow-up Patients will be recruited over 23 months Individual follow-up will last 6 months Overall duration of study will be 29 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None