Levosimendan in High Risk Heart Valve Surgery
- Registration Number
- NCT00154115
- Lead Sponsor
- Kuopio University Hospital
- Brief Summary
Prospective, randomized, double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery.
Study hypothesis: Levosimendan diminishes the need for adrenergic inotropic drugs and morbidity and may improve survival after heart valve surgery.
- Detailed Description
200 patients are prospectively randomized in a double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. Levosimendan/placebo is administered as 24 hour continuous infusion beginning after anesthesia induction. Primary endpoint being adrenergic inotrope need after cardiopulmonary bypass and secondary endpoints hospital and 6-month mortality and major organ failure.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Eligible for cardiac valve or combined CABG and cardiac valve surgery:
- Clinical signs of cardiac insufficiency
- Endocarditis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 placebo - 1 levosimendan Levosimendan
- Primary Outcome Measures
Name Time Method Heart failure necessitating inotropic drug administering after heart valve surgery Postoperative hospital period
- Secondary Outcome Measures
Name Time Method Hospital morbidity and mortality Postoperative hospital period Postoperative mortality at six months Six months postoperatively
Related Research Topics
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Trial Locations
- Locations (1)
Kuopio University Hospital
🇫🇮Kuopio, Finland
Kuopio University Hospital🇫🇮Kuopio, Finland