Spanish Randomized Clinical Trial to Compare Levosimendan Versus Placebo in Postoperative Cardiac Surgery (SPARTANS) (SPARTANS)
Cardiac Output, Low
About this trial
This is an interventional treatment trial for Cardiac Output, Low focused on measuring Poor left ventricule eyection fraction, Levosimendan, Cardiac surgery, Preoperative Treatment, Low cardiac output syndrome, Clinical Trial
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Written informed consent
- LVEF ≤35% detected by echocardiography carried out at least one week before surgery.
- Scheduled AVR or/and Scheduled CABG with CBP.
Exclusion Criteria:
- Previous levosimendan administration.
- Emergency operation.
- Kidney or liver trasplant or awaiting it.
- Hepatic cirrhosis Child C. In case Child B, contact coordinating center.
- Any degree of preoperative right ventricular failure.
- Preoperative creatinine > 2 mg / dl.
- Valve desease other than aortic.
- Renal failure requering dialysis (or creatinine clearance < 30ml / min).
- Hemodynamic instability (need for inotropics, unstable angina, acute myocardial infarction, intra-aortic balloon pump).
- Patients underwent previous cardiac surgery.
- Allergy or hypersensitivity to levosimendan or any of its excipients
- Severe hypotension (sistolic arterial tension < 80 mmHg or mean arterial pressure <50 mmHg ) and tachycardia ( heart rate >130 bpm).
- History of Torsades de Pointes.
- Pregnancy or breast-feeding
Sites / Locations
- GERMANS TRIAS I PUJOL DE BADALONA university Hospital
- Doctor Josep Trueta university Hospital
- Doctor Negrin University HospitalRecruiting
- Puerta del Hierro University Hospital
- Virgen de la Victoria University HospitalRecruiting
- A coruña UNIVERSITY HOSPITAL COMPLEX A CORUÑARecruiting
- 12 de Octubre University Hospital
- Virgen Macarena University HospitalRecruiting
- Valladolid universitary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Levosimemdam
Placebo
Levosimendan 2.5 mg / ml concentrate for solution for infusion. A 5 ml vial contains 12.5 mg of levosimendan. The concentrate is a clear solution, yellow or orange, for dilution before administration. The study drug infusion will start one day before surgery in an Intensive Care Unit with at least 8 hours of administration before surgery. A continuous infusion at 0.1 µg/kg/min will be administered to complete 24h duration.
Patients in the placebo group will receive a water-soluble vitamin B2 concentrate with 0.4 mg / ml sodium riboflavin phosphate to obtain the same color as the preparation of levosimendan and ethanol anhydrous 100 mg / ml to resemble the levosimendan odor, which will be administered at the same levosimendan infusion rate.