Status:
COMPLETED
Preoperative Levosimendan in CABG Patients With Poor LV Function
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Coronary Artery Bypass Grafting
Left Ventricular Dysfonction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 f...
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 vent...
Eligibility Criteria
Inclusion
- 18 Years and older
- scheduled for CABG with CPB
- with or without asociated cardiac repair
- ejection fraction less than 40%
- signed informed consent
Exclusion
- preoperative renal failure (creatinine clearance less than 30 ml/min)
- liver failure (prothrombine time less than 50% in the absence of vitamin K antagonist)
- cardiac surgery without CABG
- pregnancy
- emergency surgery
- known allergy to levosimendan
- severe hypotension prior to surgery
- severe tachycardia
- prior history of torsade de pointe
- dynamic obstruction od left ventricular outflow tract
- lack of signed informed consent.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT02184819
Start Date
June 1 2013
End Date
November 1 2015
Last Update
February 25 2016
Active Locations (1)
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1
Hôpital Européen Georges Pompidou, Assistance Publique Hôpitaux de Paris, France
Paris, France, 75015