Myocardial Protection
Conditions
Keywords
Levosimendan, pre-conditioning, cardiac surgery, myocardial function, contractility, heart, ischaemia
Brief summary
The aim of this study is to investigate whether pharmacological pre-treatment with levosimendan reduces intensive care unit (ICU) length of stay in patients undergoing elective myocardial revascularization under cardiopulmonary bypass.
Interventions
DRUGlevosimendan
24 μg/kg administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB
DRUGPlacebo
an identical-appearing placebo prepared and labelled by the pharmacy was administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB
Sponsors
University College London Hospitals
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥18 years * intention to perform first-time multi-vessel CABG
Exclusion criteria
* unstable angina * valvular disease * diabetes mellitus treated with sulphonylurea drugs * renal failure * severe hepatic disease * severe chronic obstructive pulmonary disease * a history of prior CABG surgery * recent myocardial infarction (MI) within the previous month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of ICU stay | two weeks |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospital stay | 3 weeks |
| Tracheal intubation time | one week |
| Inotropic support over the first 7 days | one week |
Countries
Italy
Outcome results
None listed