Intracoronary administration of levosimendan in cardiac surgery patients
- Conditions
- Dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass (AVR+CABG) operation.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-002643-10-FI
- Lead Sponsor
- Heart Center Co. Tampere University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Inclusion criteria are: a)preoperative LVEF 40% or less; b) septal wall thickness more than 11mm; c) less than moderate aortic insufficiency and d) sinus rhythm before cardiopulmonary bypass
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
Exclusion Criteria
Exclusion criteria are oesophageal disease and known allergy to levosimendan or its matabolites or adjuvants.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: We hypotize that levosimendan, delivered together with cardioplegia, can improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass operation. Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass (CPB) compared to the baseline (after induction of anesthesia).;Secondary Objective: ;Primary end point(s): Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline (after induction of anesthesia).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 15 min after separation from cardiopulmonary bypass;Timepoint(s) of evaluation of this end point: Secondary endpoints are a change in LV ejection fraction from baseline ((after induction of anesthesia) to 5 min after sternal closure and cTnT/CK-MB on the first postoperative morning.