Low Cardiac Output Syndrome
Conditions
Keywords
low cardiac output syndrome, open heart surgery, infants, Low cardiac output syndrome in infants undergoing corrective open heart surgery
Brief summary
Pediatric patients, especially infants undergoing open heart surgery have a predictable fall in cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome (LCOS). Patients, who have LCOS require more monitoring, more medication and a longer stay in intensive care unit. To prevent LCOS the phosphodiesterase inhibitor milrinone is routinely used during the first 24 hours after surgery. Levosimendan, a calcium- sensitizer improves cardiac muscle contractile force, vascular smooth muscle relaxation and coronary blood flow through calcium sensitization of the myocardial contractile filaments and opening of potassium channels without increasing oxygen consumption of the heart muscle cells. As the myocardium of infants is more calcium dependent than in later life, levosimendan should be of special benefit in this age group. The purpose of this study is to investigate whether levosimendan is superior to milrinone in preventing LCOS in infants after corrective open heart surgery.
Interventions
DRUGLevosimendan
DRUGMilrinone
Sponsors
Ludwig Boltzmann Gesellschaft
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
No
Inclusion criteria
* Age younger than one year * corrective open heart surgery with biventricular repair, except tetralogy of fallot
Exclusion criteria
* Missing written consent of parents * Weight less than 3 kg * preoperative LCOS * gestational age less than 36 weeks * preexisting renal failure * preexisting thrombopenia * preoperative cardiopulmonary resuscitation * preoperative use of milrinone or levosimendan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac output measured by a transesophageal probe | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Serum lactate levels | 48 hours |
| Cardiac output and ventricular function assessed by echocardiography | 48 hours |
| Changes in mixed venous saturation | 48 hours |
| Need of catecholamines assessed with the inotropic score | 48 hours |
| Urine output | 48 hours |
| Mean arterial, left atrial and central venous pressure | 48 hours |
Countries
Austria
Contacts
Primary ContactEvelyn Lechner, MD
Backup ContactHans Gombotz, MD, PHD
Outcome results
None listed